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OTC Monograph reform is here. The FDA recently distributed an email to all drug establishments registered as OTC manufacturers in preparation for the Over-The-Counter Monograph User Fee Program (OMUFA). OTC Monograph Reform legislation passed by congress this spring has empowered the FDA to assess fees for OTC monograph product submissions and for OTC product manufacturing facilities. The amount of the facility fee will be determined by the number of registered facilities. Facilities registered with the FDA as of December 2019 will be assessed the FY2021 OTC manufacturer facility user fee. Contract manufacture facilities that do not otherwise market OTC drug products under their own name will be assessed 2/3 of the full fee. FY2021 OTC manufacturer facility fees will be due 45 days after the fee structure has been published in the Federal Register. See the FDA website for more details.

The FDA announced a Public Meeting on the Reauthorization of the Generic Drug User Fee Amendments (GDUFA), a virtual public meeting to discuss stakeholder recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2023 through 2027. The virtual public meeting will be held on July 21, 2020, from 9 a.m. to 3 p.m., and will be held by webcast only. Please visit the meeting web page for more information and registration instructions.

In light of the ever changing landscape of regulatory decisions at CDER and CDRH and in order to keep up with the fluid needs of the COVID-19 emergency situation, please ensure you have checked the What’s New Related to Drugs and CDRHNew – News and Updates websites for the most current versions of authorized new, and authorized updated EUAs for Drugs, and / or Medical Devices. Please direct any questions on these updates to EAS and we will help you determine compliance requirements based on your products.

The FDA has updated its List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic. The FDA updates this list every six months (in June and December) to improve transparency and encourage the development and submission of ANDAs in markets with little competition. The list is separated into three sections: Part I identifies those drug products for which FDA could immediately accept an ANDA without prior discussion; Part II identifies drug products for which ANDA development or approval may raise potential legal, regulatory, or scientific issues that should be addressed with the Agency prior to considering submission of an ANDA; The Appendix identifies NDA drug products that were removed from Part I or Part II of the list because one or more ANDAs referencing such NDA drug products have been approved since the previous list publication. The PDF version of the list has full details and methodology.

The FDA’s Product-Specific Guidances for Generic Drug Development webpage has been updated to include newly added and newly revised guidances.

On June 9, 2020 the FDA announced a new version of FDA FAR 3331a submission form. The FDA has asked that the new form be downloaded and used as soon as possible. Three new fields have been added and one has been changed. A copy can be obtained on the FDA Forms website. The instruction form has also been updated.

CDRH has hosted 2 recent webinars regarding Respirators for Health Care Personnel Use during COVID-19 Pandemic. The information presented in these webinars is very helpful for those wishing to market and / or import these type products. More information can be found on the FDA website.

Guidance Document updates on the FDA website:

CDER:

Orange Book Questions and Answers

This guidance is intended to assist interested parties (including prospective drug product applicants and approved application holders) in utilizing the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book).

Bioequivalence Recommendations for Specific Products

This guidance describes FDA’s process for making available to the public FDA guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs). Under this process, applicants planning to carry out such studies in support of their ANDAs will be able to access BE study guidance on the FDA Web site rather than having to request this information from the Agency and wait for the Agency to respond as has been the case in the past.

Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors and investigators in the clinical development of drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). Specifically, this guidance addresses the FDA’s current thinking about the overall development program and clinical trial designs for drugs to support an indication for treatment of HABP/VABP.

Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of community-acquired bacterial pneumonia (CABP). Specifically, this guidance addresses the FDA’s current thinking about the overall development program and clinical trial designs for drugs to support an indication for the treatment of CABP.

Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents Draft Guidance

CDER & CBER:

Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

This guidance (Guidance 1) is the first of a series of four methodological patient-focused drug development (PFDD) guidance documents that FDA is developing to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making.

This guidance (Guidance 1) presents a general overview of methods and approaches for collecting patient experience data rather than focusing on methods for a specific, single purpose, e.g., to support collection of COA data or patient preference information. Specific issues related to COAs and patient preference information are addressed in other published FDA guidances.

CBER:

Biosimilar User Fee Amendments

Notification of annual BsUFA fees correspondence was emailed by the agency on 12 Jun 2020. Responses were due by 26 June 2020. If participation will be discontinued, a formal written request must be submitted to FDA no later than 1 August 2020. Full details are available on the website.

CVM:

CVM GFI #240 Proprietary Names for New Animal Drugs

This guidance provides recommendations to help new animal drug sponsors develop proprietary names that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance provides a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine. It also explains how you can request that CVM evaluate a proposed proprietary name.

The FDA has announced an extension to the comment period on CVM GFI #256 – Compounding Animal Drugs from Bulk Drug Substances. Interested parties will have until 15 October 2020 to submit either electronic or written comments.

Potentially of interest recently published FDA information:

FDA Compliance Program, Inspections of CDER-led or CDRH-led Combination Products implemented June 4, 2020

CDER has updated its MAPP 5220. Office of Generic Drugs Conversion of ANDA Approval to Tentative Approval Because of Court Order.

PDUFA VI: Assessment of FDA-Sponsor communication Practices During the IND Stage of Drug / Biologic Development report

CDER Report on the State of Pharmaceutical Quality: Fiscal Year 2019.

FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making website contains information and documents related to FDA’s development of the methodological PFDD guidances including public workshops, draft guidances, and hypothetical scenarios, which are all intended to serve as a basis for dialogue. For an outline of FDA’s planned timeframe for development of the guidance, please refer to the Plan for Issuance of Patient-Focused Drug Development Guidance.

Electronic Medical Device Reporting (eMDR)

The electronic Medical Device Reporting (eMDR) project provides the capability for electronic data entry and processing of medical device adverse event reports.

Medical Device Development Tools (MDDT)

The FDA’s Medical Device Development Tools (MDDT) program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices.

Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use.

List of Cleared or Approved Companion Diagnostic Devices (In Vitro and Imaging Tools) The table lists devices in the order of approval with most recently approved device at the top.

COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process June 2, 2020 publication on the FDA website of Testimony before the US Senate Committee on Finance.

Federal Register Notices of note:

FR Vol 85, No. 105 Approved Drug Products With Therapeutic Equivalence Evaluations (the ‘‘Orange Book’’); Establishment of a Public Docket; Request for Comments [Docket No. FDA–2020–N–1069]

FR Vol 85, No. 105 Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments [Docket No. FDA–2020–N–1127]

FR Vol 85, No. 105 Orange Book—Questions and Answers; Draft Guidance for Industry; Availability [Docket No. FDA–2020–D–1068]

FR Vol 85, No. 101 Guidance Documents Related to Coronavirus Disease 2019 (COVID–19); Availability

FR vol 85, No. 106 Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019

GUIDANCE DOCUMENTS intended to remain in effect only for the duration of the public health emergency:

All Divisions:

Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency

FDA is issuing this guidance to provide recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency. The guidance outlines considerations for the statistical analysis of the primary and key secondary endpoints in a trial affected by COVID-19 to help ensure that the trial will provide interpretable findings with correct statistical quantification of uncertainty.

CDER:

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

FDA is issuing this guidance in response to a number of queries from entities that are not currently licensed or registered drug manufacturers that would like to prepare alcohol-based hand sanitizers, either for public distribution or for their own internal use. The Agency is issuing this guidance to communicate its policy for the temporary preparation of certain alcohol-based hand sanitizer products by firms that register their establishment with FDA as an over-the-counter (OTC) drug manufacturer, re-packager, or re-labeler to prepare alcohol-based hand sanitizers under the circumstances described in this guidance (“firms”) for the duration of the public health emergency.

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

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 (ethanol) 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.

Temporary Policy on Prescription for Distribution of Drug Samples During the COVID-19 Public Health Emergency

FDA is issuing this guidance to address questions FDA has received asking for clarification regarding FDA’s enforcement of certain requirements relating to the distribution of drug samples under the Prescription Drug Marketing Act of 1987 during the COVID-19 public health emergency. PDMA is part of the Federal Food, Drug, and Cosmetic Act, and the relevant implementing regulations regarding drug samples are in 21 CFR part 203, subpart D.

CDER, CBER & CVM:

Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing

FDA is issuing this guidance to provide recommendations to drug and biological product manufacturers regarding: 1) Manufacturing controls to prevent contamination of drugs; 2) Risk assessment of SARS-CoV-2 as it relates to drug safety or quality; 3) Continuity of manufacturing operations

CDER & CBER:

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency.

Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators

During the COVID-19 public health emergency, the Agency has received a substantially increased volume of individual patient expanded access requests for COVID-19 investigational drugs. FDA is issuing this guidance to provide recommendations regarding the key factors and procedures Institutional Review Boards should consider when reviewing expanded access submissions for individual patient access to investigational drugs for treating COVID-19.

CDRH:

Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency (Revised)

FDA is issuing this guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for healthcare personnel (HCP)1 for the duration of the COVID-19 public health emergency.

Notifying CDRH of a Permanent Discontinuance or Interruption in of the FD&C Act During the COVID-19 Public Health Emergency (Revised) June 2020

FDA is issuing this guidance to implement section 506J of the Federal Food, Drug, and Cosmetic Act as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act as it relates to device shortages and potential device shortages occurring during the COVID-19 pandemic, for the duration of the COVID-19 public health emergency.

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

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 for the duration of the COVID-19 public health emergency.

Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face Masks and Respirators During the COVID-19 Public Health Emergency

FDA is issuing this guidance to provide recommendations for sponsors of decontamination and bioburden reduction systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA’s efficient review of such request.

CDRH & CBER:

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices – Questions and Answers

FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to device development for the duration of the COVID-19 public health emergency.

Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA is issuing this guidance to provide a policy to help address current manufacturing limitations or supply chain issues due to disruptions caused by the COVID-19 public health emergency.

COVID specific FDA webpages:

FDA Emergency Use Authorization Website EUA information and list of all current EUAs

COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process

Coronavirus (COVID-19) Update: FDA Takes Action to Protect Public Health; Increase Supply of Alcohol-Based Hand Sanitizer

Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

Personal Protective Equipment EUAs

Medical Gloves for COVID-19

Non-contact Temperature Assessment Devices During the COVID-19 Pandemic

Medical Device Types to Help Determine Section 506J Notification Obligations

Medical Device Supply Chain Notifications During the COVID-19 Public Health Emergency

Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents

Medical Devices and the COVID-19 Pandemic

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