The FDA issued a notification on 9 July 2025 regarding an FDA Imports Review Exemption Change. The agency has rescinded the FDA review exemption that had previously been applicable to importation of certain low-value FDA regulated products. Henceforth all FDA regulated products will be reviewed upon import, regardless of quantity or value. With this heightened scrutiny, ensuring all regulations are complied with (labeling, registrations, product listings, etc) is crucial. If you need support with this process, EAS is here to help.
Highlighted Guidance Documents
Conducting Remote Regulatory Assessments Questions and Answers
This final guidance makes further revisions to and replaces the revised draft guidance entitled “Conducting Remote Regulatory Assessments–Questions and Answers; Draft Guidance for Industry,” which was announced in the Federal Register on January 26, 2024 (89 FR 5244). FDA issued the revised draft guidance to describe the Agency’s thinking regarding its use of Remote Regulatory Assessments, to help increase the industry’s understanding of voluntary and mandatory RRAs, and to facilitate FDA’s process for conducting remote assessments for FDA-regulated products outside of the COVID-19 public health emergency.
The final guidance represents the current thinking of FDA on “Conducting Remote Regulatory Assessments.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Electronic Submission Template for Medical Device De Novo Requests
This guidance provides the standards for the submission of De Novo Requests by electronic format, a timetable for establishment of these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. As of October 1, 2025, FDA will require that De Novo Request electronic submissions be provided as described in this guidance.
- If you require support with the eSTAR Program, EAS has consultants that can assist.
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
The FDA is announcing the availability of a final guidance for industry entitled “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.” This final guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. This final guidance for industry revises and replaces the draft guidance of the same name issued in August 2023.
Submit Comments by 09/02/2025
DRAFT E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials | FDA
Submit Comments by 09/19/2025
All Guidance Documents can be searched on the FDA’s website.
Meetings
Compounding Quality Center of Excellence | Annual Conference
Date: August 25 – 28, 2025
Day1: Mon, Aug 25 2:00 p.m. – 05:00 p.m. ET
Day2: Wed, Aug 27 9:00 a.m. – 06:00 p.m. ET
Day3: Thu, Aug 28 9:00 a.m. – 04:30 p.m. ET
Location: Bethesda North Marriott
Hotel & Conference Center
5701 Marinelli Road
Rockville, MD 20852, United States
FDA Public Meeting: BsUFA III Regulatory Science Program Interim Public Meeting
Date: September 18, 2025
Time: 9:00 a.m. – 3:00 p.m. ET
FDA Public Workshop: Future Needs for the Development of Interchangeable Products
Date: September 19, 2025
Time: 9:00 a.m. – 1:00 p.m. ET
FDA Websites of Interest
- Stanford faculty member George Tidmarsh, M.D., Ph.D. named Director of Center for Drug Evaluation and Research
- FDA Embraces Radical Transparency by Publishing Complete Response Letters
- FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHD
- Drug Trials Snapshots Summary Report 2024
- Generic Drugs Forum (GDF) 2025 (video recording)
- RFA-FD-25-017: Reissue of RFA-FD-22-001 – Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01 Clinical Trials Optional)
Posted in Drug and Device Corner, Drugs, Medical Devices.