REMINDER: The drug and medical device establishment registration renewal and listing certification period is underway. Private Label Distributors that manage their own NDC listing submissions should be aware of the listing certification process. Deadline is 31 December 2026. Contact EAS if you need support.
The FDA issued Final Administrative Order OTC000008 on 11 September 2026 to amend Over-the-Counter Monograph M020: Sunscreen Drug Products for OTC Human use. This order removes aminobenzoic acid (PABA)4 and trolamine salicylate as sunscreen active ingredients. The final order is scheduled to take effect 11 September 2027. Read the administrative order for full details.
The FDA periodically updates their website on Predetermined Change Control Plans (PCCP). A PCCP may be submitted as part of a marketing submission for a medical device. These plans convey to the agency potential planned changes or modifications and the processes around such that the applicant proposes. See the website for further information.
Effective 21 October 2026, the FDA announced their Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations. This updated program describes how the agency will coordinate and manage all types of drug facility inspections (preapproval, postaapproval, surveillance, and for-cause). You can read more about ConOps 2.0 on the website.
Highlighted Guidance Documents
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry
The purpose of this document is to provide guidance to industry on the implementation of the mandatory cosmetics recall provisions of section 611 of the FD&C Act.
Safety Reporting Requirements for INDs and BA/BE Studies
This guidance is intended to help small businesses understand and comply with FDA’s expedited safety reporting regulations for human drug and biological products that are being investigated under an investigational new drug application or as part of a bioavailability or bioequivalence study that is exempt from the IND requirements.
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
See the website for full details
Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle
This document provides technical specifications for submitting data from a clinical trial to evaluate the ability to operate a motor vehicle to support a marketing application for drug or biological product.
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers
The FDA is announcing the availability of a final guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” This guidance provides answers to commonly asked questions from applicants and other interested parties regarding postapproval manufacturing changes made to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act. This guidance finalizes the draft guidance of the same title issued on July 23, 2024.
All Guidance Documents can be searched on the FDA’s website.
Federal Register
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Federal Register Vol 91, No. 175 Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
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Federal Register Vol 91, No. 199 Fit-for-Purpose Rare Disease Framework Initiative; Public Meeting; Request for Information and Comments
Meetings
Long-Acting Injectable (LAI) Generics: Advancing Innovation in Product Development and Regulatory Assessment – The Center for Research on Complex Generics (virtual workshop)
December 1, 2026: 8:00 am – 5:00 pm
December 2, 2026: 8:00 am – 4:30 pm
FDA Websites of Interest
- New and Updated FDA Forms
- Annual Forecast for Planned Monograph Activities
- FY 2027 GDUFA Science and Research Priorities
- Engaging with Stakeholders to Bring Nonprescription Drug Products to Market
- Drug Application Process for Nonprescription Drugs
- FDA and EMA Discuss Collaboration on Herbal / Botanical Drug Products
- FDA Issues Final Guidance on Prescription Drug Apps and Software
- Regulatory Considerations for Prescription Drug Use-Related Software
- April – June 2026 | New Safety Information or Potential Signals of Serious Risks Identified by the FDA Adverse Event Monitoring System (AEMS)
Posted in Drug and Device Corner, Drugs, Medical Devices.