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The FDA sent email reminders in February re mandatory CARES annual reporting for drug establishments, which are due now. CARES volume reporting has been an annual requirement since passing of the CARES Act in 2020. If you have not already submitted your 2020 and 2021 reports, do plan to submit these as well. EAS is here to support our clients if needed.

For those following the new MoCRA regulations, EAS is recommending that cosmetic facilities falling under the new regulation proceed with registration and product listing via the FDA’s Voluntary Cosmetic Registration Program. The voluntary system currently defines the required registrant facilities as “cosmetic manufacturing and/or packaging establishments”. Distributors can submit cosmetic product listings, although they are not required to register their facilities under the voluntary program. Although the FDA has yet to announce the registration and listing system that will be used for these submissions, it is speculated that converting the existing voluntary system into the active system will be the most efficient process. The cosmetic product listing process, if similar to OTC monograph drug product listing, will be rather time consuming for initial submissions. With a deadline of December 2023, beginning the process now will put you in a good compliance position. 

Reminder to all marketers of drug products that FDA does monitor and will issue Warning Letters to those that do not register drug establishments, and list drug products per the regulations found in 21 CFR 207. EAS is available to help our clients understand their specific requirements and how to comply.

During the height of the pandemic, many companies jumped into hand sanitizer production to assist with meeting the unprecedented demand for this drug product. The FDA has long since cancelled their emergency use authorization’s relaxed requirements which helped to make these products available to U.S. consumers. Any company still marketing hand sanitizers should be in line with 21 CFR 210 and 211 drug manufacturing GMP regulations, as well as drug establishment registration, and drug product listing. Do note, there have been warning letters issued to companies that are not in compliance. If you have questions or need support with GMP compliance or registration & listing, please contact EAS.

Highlighted Guidance Documents

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA

This guidance provides recommendations to industry on product-specific guidance meetings between FDA and a prospective applicant preparing to submit to FDA or an applicant that has submitted to FDA an abbreviated new drug application under section 505(j) of the Federal Food, Drug and Cosmetic Act. Specifically, this guidance provides information on requesting and conducting PSG meetings with FDA (PSG teleconferences, pre-submission PSG meetings, and post-submission PSG meetings), as contemplated in the Generic Drug User Fee Amendments Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027 (GDUFA III commitment letter).

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

This guideline is intended to provide recommendations on conducting bioequivalence studies during both development and post approval phases for orally administered immediate-release solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

This guidance describes the Food and Drug Administration’s regulatory and enforcement priorities regarding the compounding of certain ibuprofen oral suspension products in outsourcing facilities for administration in hospitals and health systems.

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products

This guidance provides recommendations to sponsors and investigators considering the use of externally controlled clinical trials to provide evidence of the safety and effectiveness of a drug product. In an externally controlled trial, outcomes in participants receiving the test treatment according to a protocol are compared to outcomes in a group of people external to the trial who had not received the same treatment. The external control arm can be a group of people, treated or untreated, from an earlier time (historical control), or it can be a group of people, treated or untreated, during the same time period (concurrent control) but in another setting.

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.

Surveying, Leveling, and Alignment Laser Products

FDA is issuing this guidance to outline, for manufacturers, the FDA’s approach regarding the applicability of FDA’s performance standard regulations to surveying, leveling, and alignment laser products to help manufacturers with questions they have raised. This guidance addresses topics including considerations for what is an SLA laser product, examples of SLA and non-SLA laser products, and information on variances and exemptions from SLA laser product class limits.

CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern

This document provides guidance for industry to evaluate potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.

All Guidance Documents can be searched on the FDA’s website.


Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products
Date: May 10, 2023
Time: 8:30 a.m. – 6:00 p.m.

Fiscal Year 2023 Generic Drug Science and Research Initiatives Public Workshop
Dates: May 11 – 12, 2023
Day1: Thu, May 11 8:00 AM – 4:30 PM ET
Day2: Fri, May 12 9:00 AM – 2:30 PM ET

A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
Date: March 14, 2023
Time: 10:00 AM – 12:00 PM ET

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