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Please see the end of our monthly segment for COVID-19 specific information.

The FDA issued a requirement for a stronger boxed warning about serious mental health side effects for the asthma and allergy drug montelukast. The FDA took this action after a review of available information led the agency to reevaluate the benefits and risks of montelukast use. Please review the FDA website for all relevant information.

On March 2, 2020, the FDA published their newest Product-Specific Guidances for Generic Drug Development. This batch of 43 PSGs includes: 33 new and 10 revised PSGs; PSGs for generic products for important treatments for diseases such as Amyotrophic Lateral Sclerosis (ALS), Diabetes, Human Immunodeficiency Virus (HIV), Lung cancer, and Melanoma. 38 of the PSGs are for products with no approved ANDAs (including 14 for complex products) and 16 PSGs are for complex products (10 new and 6 revised). 12 of these PSGs were developed based on research data generated by the Generic Drug User Fee Amendments (GDUFA) Science and Research program.

FDA’s Center for Drug Evaluation and Research embarked on an initiative to modernize the New Drugs Regulatory Program. Included in this program is the reorganization of the New Drugs Regulatory Program. The agency created a website publishing the Applications affected by the reorganization.

The FDA has launched FDA-Track, agency performance dashboards to offer a more concise, interactive, and visual presentation of some of the data reports in FDA’s annual performance reports. Specific to the generic drug approval process, you can review the FDA-Track; PDUFA Performance website.

The Regulatory Education for Industry (REdI) Generic Drugs Forum will be held virtually only this year on April 15 & 16 from 8 am to 4 pm EDT. 

The FDA published a news release regarding Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy. The agency is asking medical device manufacturers to communicate to health care providers and patients which medical devices could be affected by SweynTooth and ways to reduce associated risk. Please see the website for more specific information.

CVM Broadcast message #42: CVM is updating its Electronic Submission System (ESS) to assist stakeholders when submitting their Manage Forms (Form FDA 3538) through FDA ESG. This update will modify the Submission Type list of values for CVM. 1] Submission Type “Electronic Submissions” will be changed to “Manage Form”. Stakeholders should use this folder when submitting Manage Form submissions to CVM. 2] Submission Type “eSubmitter” should be used for any eSubmitter submission to CVM and 3] Submission Type “Adverse Events Reports” should be used for any electronic adverse event report submission to CVM.

Guidance Document updates on the FDA website:

All Divisions:

Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry

This guidance provides recommendations regarding the use of restricted delivery systems, to limit unintentional ingestion of oral liquid drug products by children. The recommendations in this guidance apply broadly to oral liquid drug and biological products. Accordingly, this guidance is intended for manufacturers of oral liquid drug and biological products.

CDER:

Competitive Generic Therapies

This guidance provides a description of the process that applicants should follow to request designation of a drug as a CGT and the criteria for designating a drug as a CGT. It also includes information on the actions FDA may take to expedite the development and review of ANDAs for drugs designated as CGTs.

Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control

The purpose of this guidance is to provide the Food and Drug Administration’s current recommendations regarding the overall evaluation of safety for the development of drugs and biologics indicated for improvement of glycemic control in patients with type 2 diabetes mellitus.

Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment

The purpose of this guidance is to provide FDA’s current thinking about local safety assessment for the risk of contact dermatitis (irritant, allergic, and photoallergic) during development of new drug products intended for topical application to the skin.

Safety Testing of Drug Metabolites

This guidance provides recommendations to industry on when and how to identify and characterize drug metabolites whose nonclinical toxicity needs to be evaluated.

CDER & CBER:

Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

This guidance describes recommendations for device manufacturers seeking to submit information through a CLIA waiver application to FDA to support a determination whether the device meets CLIA statutory criteria for waiver described above.

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

This document provides guidance to sponsors on the evidence necessary to demonstrate the effectiveness of investigational new drugs or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those low-prevalence rare diseases with well-characterized pathophysiology, and in which changes in substrate deposition can be readily measured in relevant tissue or tissues.

Providing Regulatory Submissions in Alternate Electronic Format

This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Q3D(R1) ELEMENTAL IMPURITIES

There are three parts of this guidance: 1] The evaluation of the toxicity data for potential elemental impurities; 2] The establishment of a permitted daily exposure (PDE) for each element of toxicological concern and 3] The application of a risk-based approach to control elemental impurities in drug products.

Inclusion of Older Adults in Cancer Clinical Trials

This guidance provides recommendations regarding the inclusion of older adult patients in clinical trials of drugs for the treatment of cancer. For the purpose of this guidance, older adults are those aged 65 years and older.

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

This guidance is intended to provide answers to common questions about FDA’s implementation of the “transition” provision of the Biologics Price Competition and Innovation Act of 2009 under which an application for a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act as of March 23, 2020, will be deemed to be a license for the biological product under section 351 of the Public Health Service Act on March 23, 2020 (the transition date).

CDRH:

Product Labeling for Laparoscopic Power Morcellators

This draft guidance contains recommendations concerning the content and format for certain labeling information for laparoscopic power morcellators (LPMs). The recommendations in this draft guidance reflect the state of the science and available technology regarding use of LPMs and are being made in light of scientific information that suggests that the use of these devices contributes to the dissemination and upstaging of an occult uterine malignancy in women undergoing laparoscopic gynecologic surgery for presumed fibroids.

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

The purpose of this guidance is to assist manufacturers in using the Dual 510(k) and Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application pathway.

510(k) Third Party Review Program

The objectives of this guidance are: 1] To describe the factors FDA will use in determining device type eligibility for review by 3P510k Review Organizations; 2] To outline FDA’s process for the recognition, re-recognition, suspension, and withdrawal of recognition for 3P510k Review Organizations and 3] To ensure consistent quality of work among 3P510k Review Organizations through the Medical Device User Fee Amendments (MDUFA) IV commitments authorized under FDARA7 to eliminate the need for routine, substantive re-review by FDA.

Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery

FDA has developed this guidance document to assist industry in preparing premarket notification (510(k)) submissions for electrosurgical devices intended for use in general surgery. These devices are designed to cut and/or remove tissue and control bleeding through the use of high-frequency electrical current. For the purpose of this guidance, electrosurgical devices may also be called radiofrequency (RF) devices or high-frequency (HF) devices.

Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway

This draft guidance provides performance criteria for soft (hydrophilic) daily wear contact lenses in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for soft (hydrophilic) contact lenses will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

Bone Anchors – Premarket Notification (510(k)) Submissions

This guidance document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices. These devices are indicated for attachment of soft tissue to bone. This final guidance clarifies and provides current thinking on the recommended content for a bone anchor 510(k) submission, including performance testing recommendations and device description.

CBER:

Biological Product Deviation Reporting for Blood and Plasma Establishments

FDA is providing blood or plasma establishments, with revised recommendations related to biological product deviation (BPD) reporting. This guidance document is intended to assist blood and plasma establishments in determining when a report is required, who submits the report, what information to submit in the report, the timeframe for reporting, and how to submit the report.

CVM:

CVM GFI #264 Standardized Medicated Feed Assay Limits

This guidance recommends a standardized set of assay limits for medicated feeds. If you have any questions or concerns please email CVMDCU@fda.hhs.gov

CVM GFI #108 Registering with CVM’s Electronic Submission System

This guidance provides general standards which should be used to register with the Center for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS).

COVID-19 Specific information

The FDA has established a Coronavirus Disease 2019 (COVID-19) webpage for their most up to date information. 

In response to the current medical health crisis, the FDA has issued three guidance documents regarding the manufacture of alcohol-based hand sanitizer products. Two of these guidance documents communicate the agency’s policy for the temporary manufacture of certain alcohol-based hand sanitizer products. The third describes the agency’s policy for entities that wish to produce alcohol for incorporation into alcohol-based hand sanitizers. These guidance documents will only be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency

Due to the Coronavirus Disease 2019 (COVID-19) pandemic, the Food and Drug Administration (FDA or Agency) has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. This is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.

FDA is issuing this guidance in response to a number of queries from entities that are not currently registered drug manufacturers that would like to produce alcohol for incorporation into alcohol-based hand sanitizers. This policy does not extend to other types of active ingredients for incorporation into alcohol-based hand sanitizers, such as isopropyl alcohol. The Agency is issuing this guidance to communicate its policy for the temporary manufacture of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products under the circumstances described in this guidance (alcohol production firms) for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. At such time when the public health emergency is over, as declared by the Secretary, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance 

Further COVID-19 specific Guidance Documents:

Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability of ventilators as well as other respiratory devices and their accessories during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease-2019 (COVID-19 ) Public Health Emergency

FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the Secretary in accordance with section 319(a)(2) of the PHS Act.

Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency Guidance for Industry and Health Care Professionals

FDA is issuing this guidance to communicate its temporary policy for certain risk evaluation and mitigation strategies (REMS) requirements for the duration of the public health emergency (PHE) declared by the Secretary of Health and Human Services (HHS) on January 31, 2020. The policy outlined in the guidance will be in effect only for the duration of the public health emergency.

Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency

The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.

Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic

This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic, industry and FDA workforces may be reduced because of high employee absenteeism while reporting of adverse events related to widespread use of medical products indicated for the treatment or prevention of the pathogen causing the pandemic may increase. The extent of these possible changes is unknown. This guidance discusses FDA’s intended approach to enforcement of adverse event reporting requirements for medical products and dietary supplements during a pandemic.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic.

CVM GFI# 269 Enforcement Policy Regarding Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID-19 Outbreak

FDA is aware that during the COVID-19 outbreak some States are modifying their requirements for veterinary telemedicine, including State requirements regarding the veterinarian-client-patient relationship (VCPR). Given that the Federal VCPR definition requires animal examination and/or medically appropriate and timely visits to the premises where the animal(s) are kept, the Federal VCPR definition cannot be met solely through telemedicine. To further facilitate veterinarians’ ability to utilize telemedicine to address animal health needs during the COVID-19 outbreak, FDA intends to temporarily suspend enforcement of a portion of the Federal VCPR requirements. Specifically, FDA generally intends not to enforce the animal examination and premises visit VCPR requirements relevant to FDA regulations governing Extralabel Drug Use in Animals (21 CFR part 530) and Veterinary Feed Directive Drugs (21 CFR 558.6). Given the temporary nature of this policy, we plan to reassess it periodically and provide revision or withdrawal of this guidance as necessary.

COVID-19 specific FDA announcements / websites:

85 FR 16949 Process for Making Available Guidance Documents Related to Coronavirus Disease 2019

Emergency Use Authorizations

FAQs on Diagnostic Testing for SARS-CoV-2

Coronavirus (COVID-19) Update:  FDA allows expanded use of devices to monitor patients’ vital signs remotely

Letter to Industry on COVID-19 (Medical Device Establishments)

CSMS #42124872 -Information for Filing Personal Protective Equipment and Medical Devices During COVID-19 Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers.

Investigational COVID-19 Convalescent Plasma – Emergency INDs

Posted in Drug and Device Corner, Drugs, Medical Devices.