Category Archives: Drug and Device Corner

January 2019 Drug and Device Corner

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With the Federal Register (FR) publication unavailable, the FDA has published Safety and Performance-Based Pathway on the Guidance Document webpage. Full details will be available in the Federal Register once that site is again functioning. The existing Docket Number for this document is 

FDA-2018-D-1387. For questions about this document regarding CDRH-regulated devices, contact the 510(k) Staff at 301-796-5640. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.

Guidance Document updates on the FDA website

CDER

ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs

CDER & CBER

Rare Diseases: Common Issues in Drug Development

Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway

Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection

REMS Assessment: Planning and Reporting

CDRH

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

FDA’s CDRH recently released a Safety and Performance-Based Pathway Guidance Document describing a new abbreviated submission process for 510(k)s which aims to simplify submissions for devices which meet performance standards developed by FDA rather than showing outright equivalence in safety/efficacy to the predicate device. This new pathway has the potential for reducing the administrative burden of building a lengthy clearance dossier as well as be a slightly faster way to gain review and clearance. More information will be forthcoming as FDA issues future guidance on the application of this Safety and Performance-Based Pathway to certain types of devices with corresponding FDA-identified performance criteria. Industry may suggest device types for which FDA should consider identifying performance criteria.

Drug and Device January 2019

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Guidance Document updates on the FDA website

All centers:

Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products

CDER:

Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis:  Developing Drugs for Treatment

Post-Complete Response Letter Meetings Between FDA and ANDA Applicants

Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

CDER & CBER:

New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2)

Questions and Answers on Biosimilar Development and the BPCI Act

The “Deemed to be a License” Provision of the BPCI Act Questions and Answers Guidance for Industry

Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009

Biomarker Qualification: Evidentiary Framework

Data Integrity and Compliance With Drug CGMP Questions and Answers

Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics

Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

CDRH & CBER:

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

CDRH:

Recommendations for Dual 510(k) and CLIA Waiver by Application Studies

Select Updates for Recommendations Select Updates for Recommendations Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment

Breakthrough Devices Program

CBER:

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

Labeling of Red Blood Cell Units with Historical Antigen Typing Results

CVM:

Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing MRLs and Withdrawal Periods

Drug and Device Corner 2018 December

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Guidance Document updates on the FDA website:

All centers:

  • Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA Guidance for IndustryOn December 3, 2018, the U.S. Food and Drug Administration (FDA) published the guidance for industry entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The final guidance provides recommendations to industry on Post-complete response letter (CRL) meetings between the FDA and abbreviated new drug application (ANDA) applicants to clarify deficiencies identified in a CRL to an ANDA submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act.

CDER:

CDER & CBER:

CDRH & CBER:

CBER:

Drug and Device Corner 2018 October

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The FDA has announced their FY 2019 Animal Drug User Fee Rates for ADUFA and AGDUFA, please follow link for full information.

Please see the FDA webpage for updates on valsartan recalls.

Guidance Document updates on the FDA website:

All centers:

CDER:

CDER & CBER:

CDRH:

CBER:

Remember to keep up with CDER Product – Specific Guidances for Generic Drug Development. October had 2 new guidances and 23 revisions.

Drug and Device Corner 2018 September

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EAS would like to remind clients, the FDA FY 2019 establishment registration renewal period begins this month. With reference to Drug Establishments, please make sure you are aware of your obligations under the Drug Supply Chain Security Act (DSCSA) during this drug listing certification period. The FDA has released several guidance documents to assist.

In the event you not already seen the Statement from FDA Commissioner Scott Gottlieb, M.D, EAS highly recommends you read this to understand the FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities. The statement includes a link to the FDA’s published internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections.

In addition, FDA recently announced a Special 510(k) Program Pilot, which aims to expand upon the types of changes eligible for the Special 510(k) Program to improve the efficiency of 510(k) review. FDA is working to simplify the review of certain 510(k)s for industry and FDA staff using efficient practices consistent with least burdensome principles. As part of this pilot, certain design or labeling changes that previously were reviewed as a Traditional 510(k) may be eligible to be reviewed through the Special 510(k) pathway instead. The Agency believes that the reliance on design control requirements and previous Agency review of detailed information can reduce review times and still protect the public health. This pilot is part of ongoing efforts to simplify the 510(k) process and help promote timely access to safe, effective, and high-quality medical devices.  EAS offer 510(k) review and submission assistance. Please contact us for more information.

Guidance Document updates on the FDA website:

All centers:

Postapproval Changes to Drug Substances

Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank

CDER:

Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers

Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy

Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier

Allergic Rhinitis: Developing Drug Products for Treatment

Nonallergic Rhinitis: Developing Drug Products for Treatment

Physiologically Based Pharmacokinetic Analyses — Format and Content

Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Technical Specifications—Comparative Clinical Endpoint Bioequivalence Study Analysis Datasets for Abbreviated New Drug Applications

FDA Product-Specific Guidances for Generic Drug Development webpage

FDA in Brief: FDA issues 54 product-specific guidances to promote generic drug access and drug price competition 

CDER & CBER:

Hematologic Malignancy and Oncologic Disease: Considerations for User of Placebos and Blinding in Randomized Controlled Clinical Trials for Drug Product Development

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

CDRH:

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing

Recognition and Withdrawal of Voluntary Consensus Standards

510(k) Third Party Review Program

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

Drug and Device Corner 2018 August

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The FDA recently sent a reminder email to registered drug establishments regarding the Drug Supply Chain Security Act’s (DSCSA) impending requirements. Production of a prescription drug that meets the definition of “product” (see section 581(13) of the FD&C Act noted below), now requires manufacturers to affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced into commerce by November 28, 2018. A product identifier should include the product’s NDC, unique serial number, lot number and expiration date (see section 581(14) of the FD7C Act) in human- and machine-readable formats. The machine-readable format shall be a 2-dimensional (2D) data matrix barcode when affixed to or imprinted on a package or a linear or 2D data matrix barcode when affixed to or imprinted onto a homogeneous case of the product (see section 582(a)(9) of the FD&C Act).

Section 581(13): “(13) Product.–The term ‘product’ means a prescription drug in a finished dosage form for administration to a patient without substantial further manufacturing (such as capsules, tablets, and lyophilized products before reconstitution), but for purposes of section 582, does not include blood or blood components intended for transfusion, radioactive drugs or radioactive biological products (as defined in section 600.3(ee) of title 21, Code of Federal Regulations) that are regulated by the Nuclear Regulatory Commission or by a State pursuant to an agreement with such Commission under section 274 of the Atomic Energy Act of 1954 (42 U.S.C. 2021), imaging drugs, an intravenous product described in clause (xiv), (xv), or (xvi) of paragraph (24)(B), any medical gas (as defined in section 575), homeopathic drugs marketed in accordance with applicable guidance under this Act, or a drug compounded in compliance with section 503A or 503B.”

More information about the DSCSA can be found on FDA’s website.

We would like to remind our clients, that beginning 1 October 2018, VMF sponsors will be required to use eSubmitter to submit all animal drug applications to the agency. The FDA has been hosting webinars to teach interested parties on the process. You can download the eSubmitter program from the FDA website and find recordings of the instructional webinars, when available, here.

Manufacturers of sunscreen products have an opportunity to offer FDA comments on SPF testing and drug facts labeling through 18 October 2018, please see instructions at the Federal Register notice docket# FDA-2011-N-0449.

On 10 August 2018, the FDA published a revision to the Manual of Policies and Procedures (MAPP 5240.5), ANDA Suitability Petitions – link will bring you to the document for review.

The FDA has announced via the Federal Register Vol 83, No. 163, their determination that Danocrine (danazol) capsules, 50 mg, 100 mg and 200 mg were not withdrawn from sale for reasons of safety or effectiveness, except with respect to the indication of fibrocystic breast disease that was withdrawn for reasons of safety or effectiveness. As a result, the FDA will not be suspending approval of ANDAs that refer to this drug product as long as the applications have removed the indication for fibrocystic breast disease. This determination will also allow the FDA to continue to approve ANDAs that refer to this drug as long as they meet relevant legal and regulatory requirements.

Per the FDA Reauthorization Act of 2017, the FDA has identified a list of Medical Device accessories proposed to be classified as class I, and distinct from other devices. The FDA welcomes public comment until 16 October 2018 on their proposal. Full details and information on how to comment can be found by following this link to the Federal Register notification.

The FDA has announced several public meetings that may be of interest to our readers, please see details below.

The FDA will hold a public hearing with an opportunity for public comment on the future format of the National Drug Code (NDC). With the availability of 5-digit labeler codes nearing capacity, the FDA is open to input from stakeholders on their perspectives regarding the impact of any future changes made to the length and format of the NDC. The hearing is to be held 5 November 2018 from 8:30 am to 5:00 pm EST. Registration for online attendance is available. If you wish to attend in person or present at the public hearing, you must register no later than 15 October 2018. Further information and a registration link can be found here.

Public Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee will be held 20 September 2018, at FDA’s White Oak Campus, in Silver Spring, MD. The FDA plans to provide a live webcast of this meeting. The morning session will focus on the modernization of assessing drug applications through a Knowledge-Aided Assessment and Structured Application (KASA) initiative. The afternoon session will focus on in-vitro/in-vivo relationship standards and will seek input on establishing patient-focused dissolution standards for oral solid modified-release dosage forms. Complete details can be found at the Federal Register Vol. 83, No. 158.

There will be a public meeting entitled “Standardized Data for Pharmaceutical Quality / Chemistry Manufacturing and Control (PQ/CMC)” on 19 October 2018 from 9 am to 4 pm EDT. The purpose is to provide members of the pharmaceutical industry, and other interested parties, an opportunity to discuss with FDA and provide input on related topics and issues. Please see the Federal Register Notice for complete details.

The FDA has published the following user fee rates for their FY2019 which runs from 1 Oct 2018 – 30 Sept 2019:

Generic Drug User Fee Rates for Fiscal Year 2019

Medical Device User Fee Rates for Fiscal Year 2019

Prescription Drug User Fee Rates for Fiscal Year 2019

Outsourcing Facility Fee Rates for Fiscal Year 2019

Biosimilar User Fee Rates for Fiscal Year 2019

Guidance Document updates on the FDA website:

All centers:

Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices and Biological Products for Treatment

CDER:

Fluticasone Propionate Draft Guidance

Nonclinical Testing of Orally Inhaled Nicotine – Containing Drug Products

Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of drugs for Medication – Assisted Treatment

Quality Attribute Considerations for Chewable Tablets

Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations

CDER & CBER:

Elemental Impurities in Drug Products

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics

CDRH:

Peripheral Vascular Atherectomy Devices – Premarket Notification [510(k)] Submissions

Medical Device User Fee Small Business Qualification and Certification

Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

CBER:

Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis

OOPD: (office of orphan products development)

Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases

Drug and Device Corner 2018 July

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EAS would like to bring to your attention the Draft Guidance released by the FDA for ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA. This guidance describes the significant difference between GDUFA I and GDUFA II Amendments and the timelines associated with their review. The FDA considers all submissions to an ANDA to be an amendment, they will be classified based on the content and issued a goal date consistent with that classification. Please review the guidance for further details.

In the FDA’s ongoing effort to make generic affordable drugs available to the public, they have published product-specific guidances describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs. These guidances are hoped to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating the evidence needed to support ANDA approval. Please see the FDA’s Product-Specific Guidances for Generic Drug Development webpage for more details.

The FDA issued a press release regarding its recent actions on bulk drug substances used for compounding. Their Bulk Drug Substances Nominated for Use in Compounding lists for 503A Category drugs and 503B Category drugs have been updated as of 23 July 2018. Included in the update are the changes to the lists and when the changes became effective. Please see the press release for full details. 

The Food and Drug Administration (FDA) announced a public hearing to solicit input from the public on how to facilitate greater availability of biosimilar and interchangeable products while retaining the balance between competition and innovation. The hearing will be held on Tuesday 4 September 2018, from 9 a.m. to 5 p.m. at the Food and Drug Administration’s White Oak Conference Center. If you would like to participate and weigh in on this hearing, more information on how to register for the meeting or the live webcast can be found in the Federal Register Notice.

Guidance Document updates on the FDA website

All centers

Use of Electronic Health Record Data in Clinical Investigations

CDER

Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations

Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention

Q3D(R1) Elemental Impurities

Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs

Innovative Approaches for Nonprescription Drug Products

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

Use of Liquids and / or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations

CDER & CBER

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017

Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products – Content and Format

E17 General Principles for Planning and Design of Multiregional Clinical Trials

Field Alert Report Submission Q & A

Labeling for Biosimilar Products

Inborn Errors of Metabolism That use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development

Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies

E17 General Principles for Planning and Design of Multiregional Clinical Trials

CDRH

Metal Expandable Biliary Stents – Premarket Notification (510(k)) Submissions

CBER

Human Gene Therapy for Retinal Disorders

Long-Term Follow-Up After Administration of Human Gene Therapy Products

Human Gene Therapy for Rare Diseases

Chemistry, Manufacturing and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

Human Gene Therapy for Hemophilia

Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up

Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)

CVM

Antimicrobial Animal Drug Sales and Distribution Reporting

#257 Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species

June 2018 Drug and Device Corner

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Federal Register Notice Vol 83, No. 108

FDA is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the FD&C Act permitting the exemption of a device from the requirement to submit a 510(k).

FDA Withdraws Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity

[6/21/2018] The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a draft guidance for industry entitled “Statistical Approaches to Evaluate Analytical Similarity,” issued in September 2017. The draft guidance, if finalized as written, was intended to provide advice for sponsors developing biosimilar products regarding the evaluation of analytical similarity between a proposed biosimilar product and the reference product. After considering public comments that the agency received about the draft guidance, the FDA determined it would withdraw the draft guidance as it gives further consideration to the scientific and regulatory issues involved. Comments submitted to the docket addressed a range of issues that could impact the cost and efficiency of biosimilar development, including the number of reference product lots the draft guidance would recommend biosimilar developers sample in their evaluation of high similarity and the statistical methods for this evaluation. The FDA believes that in better addressing these issues in the future, the agency can advance principles that can promote a more efficient pathway for the development of biosimilar products.

The agency intends to issue future draft guidance that will reflect state-of-the-art techniques in the evaluation of analytical data to support a demonstration that a proposed biosimilar product is highly similar to a reference product.

Guidance Document updates on the FDA website

All Centers

Medical Product Communications That Are Consistent With the FDA-Required Labeling – Q & A

CDER

Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

Prescription Drug User Fee Act Waivers for Fixed-Combination Antiretroviral Drugs for the President’s Emergency Plan for AIDS Relief

Complicated Urinary Tract Infections: Developing Drugs for Treatment

Assessment of Pressor Effects of Drugs

Complicated Intra-Abdominal Infections: Developing Drugs for Treatment

Major Depressive Disorder: Developing Drugs for Treatment

CDER & CBER

Limited Population Pathway for Antibacterial and Antifungal Drugs

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials

Development of a Shared System REMS

Waivers of the Single, Shared System REMS

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – Core Guideline

Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management – Annex

Prescription Drug User Fee Act Waivers, Reductions, and Refunds for Drug and Biological Products

CDRH

Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests

Intravascular Catheters, Wires and Delivery Systems with Lubricious Coatings – Labeling Considerations

Coronary, Peripheral and Neurovascular Guidewires – Performance Tests and Recommended Labeling

Humanitarian Device Exemption (HDE) Program

Recommended Content and Format of Complete Test Reports for Non-Clinical Bench Performance Testing in Premarket Submissions

CDER & CDRH

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities Q & A

CDER & CBER

S9 Nonclinical Evaluation for Anticancer Pharmaceuticals Q & A

Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

CVM

General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals

May Drug and Device Corner

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In the ongoing effort to make more affordable drugs available to the public, FDA Commissioner Scott Gottlieb, MD issued a statement on the FDA’s efforts to assist in this process. Of particular note is the FDA’s commitment to ensuring generic drug developers have access to brand drug samples for their development process. You can read the commissioners statement here.

The U.S. House Energy and Commerce Committee has progressed with legislation to reform and modernize the OTC Monograph System. Included in this reform is a discussion of an OTC user fee program similar to that of PDUFA, GDUFA, and BsUFA. The FDA sees an OTC monograph user fee program as a means of resources that would encourage innovation and fund the necessary regulatory system update. Currently, each ingredient-specific monograph must be finalized through a multi-step public rulemaking process. This new legislation is proposing an administrative order process to replace the current procedures. EAS will keep you updated as this legislation evolves.

We want to bring to your attention the recently released Enforcement Policy – OTC Sunscreen Drug Products Marketed Without an Approved Application Guidance Document. In this guidance, the FDA articulates its enforcement approach for OTC sunscreen drug products that are being marketed without an approved application as well as those included in the final monograph (for which the effective date has indefinitely stayed.) We highly recommend reviewing this document to find out where your sunscreen products fall in regard to the formulation, testing, and labeling requirements and how this new enforcement policy may affect their continued marketing. To read FDA Commissioner Scott Gottlieb, MD’s statement regarding sun exposure and sunscreens, please follow this link.

The FDA has announced in the Federal Register Vol 83, No. 87 their final order regarding the General Hospital and Personal Use Needle Destruction Device. Effective 4 June 2018, this device will be renamed “sharps needle destruction device” and reclassified from a class III device (regulated under product code MTV) into class II (special controls) which will make it subject to premarket notification. The reclassification will lessen the burden on industry for marketing such devices while still ensuring reasonable safety and effectiveness for users.

The FDA has published in the Federal Register Vol 83, No 94 a proposed amendment to regulations concerning the classification of products as biological products, devices, drugs or combination products. The agency will be accepting e-comments on their proposed amendment until midnight ET 16 July 2018.

The FDA has a webpage dedicated to Drug Supply Chain Security Act readiness, please follow the link for further information. There have also been 3 draft guidance documents released in 2018 regarding the Drug Supply Chain Security Act. The link will bring you to the FDA page listing each of these documents.

Guidance Document updates on the FDA website

CDER

CDER & CBER

CVM

April 2018 FDA Drug / Medical Device Activity

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Reminder! 5 May 2018 is the date for DMF (Drug Master File) and IND (Investigational New Drug) applications to comply with eCTD format submission. There has been a delay for Type III DMF files to comply. The FDA announced in April via their Guidance Document Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications that Type III DMF files will have until 5 May 2019 in order to comply with the eCTD format requirements. With the exception of Type III DMFs, all files not submitted in eCTD beginning 5 May 2018 will be rejected. Please see the FDA Drug Master File Tip Sheet for further information. If you have any questions, please do not hesitate to contact EAS.

We would like to bring to your attention the FDA draft Guidance Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria. Please note, comments on this draft are due to the FDA no later than 90 days after publication in the Federal Register(which was 12 April 2018). This draft guidance proposes to provide an optional pathway for certain well-understood device types which the FDA would identify on a list maintained on the FDA website. Rather than a direct comparison to the predicate device for a 510(k) submission, the FDA proposes to provide alternate objective performance criteria that would satisfy demonstrating substantial equivalence for performance relevant to safety and effectiveness. This will comply with the new congressional amendment to the FD & C Act for the “least burdensome” provisions for medical devices.

Guidance Document updates on the FDA website: CDER:

CBER:

CDHR:

CVM:

CDER & CBER:

CDRH & CBER:

March 2018 FDA Drug / Medical Device Activity

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EAS would like to bring to your attention, the Statement from FDA Commissioner Scott Gottlieb, MD regarding drug compounding outsourcing facilities. The Drug Quality and Security Act (DQSA) was enacted by Congress in 2013 in response to a significant safety issue experienced by the public as the result of poor drug compounding practices. As seen with recently issued warning letters, the FDA is also prioritizing enforcement of section 503B of the Federal Food, Drug and Cosmetic Act which allows for compounded drugs which are not FDA-approved and do not undergo premarket review by the FDA for safety, effectiveness, and quality. In the FDA’s ongoing efforts to enact measures to ensure this allowance is exercised only when necessary and appropriate, and in a safe manner with assured product quality, they have released the Draft Guidance Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug and Cosmetic Act. In this guidance, the FDA addresses their plan to formulate the “503B bulks list”, a list of bulk drug substances determined by the FDA as clinically necessary for outsourcing facilities to use for compounding drugs. Follow the links for further information.

Now that the dust has settled with the 2017 FDA requirement to certify all drug listings annually, we would like to bring to your attention the necessity to complete expired listings. Under 21 CFR 207.57(b), registrants must submit updated listing information at each June and December if there is change since the previous listing and they must submit this information to the FDA via electronic format. These changes include any drug recently introduced into U.S. commercial distribution which was not previously listed, any drug which commercial distribution has been ceased, any drug reintroduced in commercial distribution and any material changes in any drug listing information previously submitted. The FDA has communicated that although listings that were not certified by 31 December 2017 have been changed to an expired status, it is still required to ‘complete’ the marketing status and input an ‘end marketing date’ in order to delist the product. EAS is here to assist with any listing issues you may need to be resolved. Please let us know if we can help.

Guidance Document updates on the FDA website:

OC: Immediately in Effect Guidance for Industry and Food & Drug Administration Staff

CDER:

CDHR:

CVM:

OC: Distributed for Comment Purposes Only

 

February 2018 FDA Drug / Medical Device Activity

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Medical Device manufacturers and importers, please make note of the upcoming FDA Adverse Event codes update. Per the FDA eMDR System Enhancements website, the list of FDA Adverse Event codes accepted in F10 and H6 will be updated to harmonize with the IMDRF Adverse Event Reporting Terminologies. This update will affect the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to IMDRF Annexes A through D. Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not currently accepted by eMDR, but the new hierarchies posted on FDA.gov include a one-to-one mapping of IMDRF codes to FDA codes. FDA codes that are being retired during this update will be rejected by eMDR once this update is deployed. The current non-harmonized hierarchies and the future IMDRF-harmonized hierarchies are currently posted at MDR Adverse Event Codes. The scheduled date of this production update is 6 April 2018.

Senior Director for Pharmaceuticals and Medical Devices, Bryan J. Coleman has summarized a new agency guidance on Refuse to Accept (RTA)’s for 510(k) Medical Device applications. In this summary, Bryan discusses FDA’s newly produced checklists enabling submitters to ensure all required data is complete prior to submission. This should better facilitate FDA’s ability to complete a substantive review by assuring all preliminary information is included. EAS offers services with 510(k) submissions including the review of data and assistance with compiling submissions to the process of submitting to FDA. Please contact Bryan at bcoleman@easconsultinggroup.com

Guidance Document updates on the FDA website:

CDER:

CDRH:

January 2018 FDA Drug / Medical Device Activity

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EAS would like to remind all DMF holders that the FDA DEADLINE for eCTD submissions is fast approaching. As of 5 May 2018, the FDA will only accept eCTD submissions to ALL DMF files. If you have not already made plans for conversion, you should do so immediately. If you have any questions, feel free to contact EAS. While on the topic of DMFs Albert Yehaskel, EAS Independent Advisor for Pharmaceutical Submissions, has written a very informative white paper, “An Overview of Drug Master Files”. This has been slightly updated and added to our website, please use this link to access this valuable resource.

The Food and Drug Administration is reopening the comment period for the document published in the Federal Register on September 26, 2017, announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the sponsor for the approved, marketed drug does not wish to pursue or collaborate on the new use. Submit either electronic or written comment by February 21, 2018.

In the event you missed the FDA announcement, the agency has created a new platform to request pre-ANDA meetings. This platform, CDER Direct NextGen Collaboration Portal, was designed to help the FDA minimize manual data entry and support the agency’s GDUFA II performance goals. The new technology platform, which will allow the industry to request pre-ANDA meetings for complex generic drug products with the FDA. In just a few steps, potential applicants of abbreviated new drug applications (ANDAs) will be able to initiate requests by uploading a meeting request package. The portal also allows the industry to submit supporting documents, such as meeting presentation materials, requests for additional information made by the FDA, and post-meeting comments. For additional information about the portal, please visit the FDA Pre-ANDA Program webpage.

FDA (or Agency) is announcing the timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs, and certain INDs to CBER and CDER. The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36 months for certain INDs after the publication of the final guidance “Providing Regulatory Submissions in Electronic Format–Standardized Study” in December 2014. When future updates to study data standards listed in the FDA Data Standards Catalog (Catalog) occur, these updated standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice announcing such updates is published. When future new study data standards are listed in the Catalog, these new standards will be required in studies with a start date no earlier than 24 months after a Federal Register notice announcing such new standards is published. Please see the FDA Study Data Standards Resources webpage for further information.

Guidance Document updates on the FDA website: CDER:

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December 2017 FDA Drug / Medical Device Activity

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We would like to highlight one of the Draft Guidance issued by the FDA this month.**The U.S. Food and Drug Administration proposed a new, risk-based enforcement approach to drug products labeled as homeopathic. This proposed new approach would update the FDA’s existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices. Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product.

With the new drug listing regulation, all companies have been given a renewed opportunity to ensure their listings are complete and accurate. This includes the label uploaded to the drug listing. The FDA recently issued a warning letter to a company whose listing did not match the product in commercial distribution. Do keep in mind that the FDA requires all changes to a drug listing to be reported as soon as possible but no later than the June or December following the change. As of FDA FY 2018, all drug listings must be certified as accurate by 31 December of each year. Any listing that has not been updated or certified as accurate according to the regulation will be considered expired by the FDA in January of the following year.

Guidance Document updates on the FDA website:

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