Highlighted Guidance Documents
The Food and Drug Administration is announcing the availability of a final guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter monograph drugs or organizations nominated by sponsors or requestors to represent their interests in a proceeding and discusses the procedures and principles for these formal meetings. This guidance finalizes the draft guidance of the same title issued on February 7, 2022.
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence | FDA
The Food and Drug Administration is announcing the availability of a final guidance for industry titled “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence.” This guidance provides recommendations to applicants who submit abbreviated new drug applications for topical dermatologic corticosteroids of all potency groups (referred to in this notice as topical corticosteroids). The guidance describes recommendations for an in vivo pharmacodynamic approach to demonstrate the bioequivalence (BE) of topical corticosteroids. This guidance provides clarity for potential ANDA applicants on the appropriate pilot dose duration vasoconstrictor response and pivotal vasoconstrictor BE studies and other recommendations for pharmacodynamic approaches to assess the BE of topical corticosteroids. This guidance finalizes the draft guidance of the same title “Topical Dermatologic Corticosteroids: In Vivo Bioequivalence” issued on October 24, 2022, and replaces the guidance for industry of the same title issued on June 2, 1995.
This guidance describes how FDA applies flexibility to the chemistry, manufacturing, and controls (CMC) requirements for human cellular and gene therapy (CGT) products being developed for biologics license applications (BLAs). Consistent with the statutory and regulatory requirements for biological products, FDA uses a flexible approach to ensuring applicable CMC requirements are met for CGT products. FDA’s flexible approach serves to help expedite development, review, and patient access to safe and effective CGT products to treat serious or life-threatening conditions that represent significant unmet medical needs.
DRAFT Master Protocols for Drug and Biological Product Development
Submit Comments by 08/24/2026
All Guidance Documents can be searched on the FDA’s website.
Federal Register
FR Vol 91, No. 132: Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
Meetings
Date: August 5, 2026
Time: 10:00 a.m. – 3:00 p.m. ET
Date: August 27, 2026
Time: 8:30 a.m. – 12:30 p.m. ET
Date: September 1, 2026
Time: 12:00 p.m. – 4:00 p.m. ET
Date: September 23 – 24, 2026
Day1: Wed, Sep 23 8:00 a.m. – 04:30 p.m. ET
Day2: Thu, Sep 24 8:00 a.m. – 04:30 p.m. ET
Location: Attend In Person or Virtually
The Universities at Shady Grove
Building II
9630 Gudelsky Drive
Rockville, MD 20850
United States
Three-Part Town Hall Series on Medical Devices and Biocompatibility
Town Hall – Biocompatibility Risk Assessment
Date: September 9, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
Town Hall – Biocompatibility and Chemical Characterization Testing – Extractions
Date: September 23, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates
Date: September 29, 2026
Time: 8:45 a.m. – 4:00 p.m. ET
Location: Attend In Person or Online Via Adobe Connect
FDA White Oak Campus
10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
United States
Town Hall – Biocompatibility and Toxicological Risk Assessment
Date: October 7, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
ICYMI (In Case You Missed It)
- When AI Isn’t Enough: Human Expertise Remains Essential in Regulatory Affairs by EAS President Dean Cirotta
Posted in Drug and Device Corner, Drugs, Medical Devices.