EAS has become aware of the agency’s increased enforcement policy described in their Guidance Document Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. For extension requests that identify the same reason for the request multiple times, FDA is beginning to deny subsequent extension requests. Please keep this in mind when requesting a Complete Response extension. You may review the guidance document on the agency’s website.
For the first time in 20 years, the FDA has approved a new active ingredient for sunscreen products. The proposed order adding Bemotrizinol as an approved active ingredient to the monograph was issued 12 December 2025 in response to an OMOR filed by DSM Nutritional Products LLC. After the required comment period which ended 26 January 2026, the FDA reviewed data submitted in the OMOR, existing literature, and the comments submitted to docket FDA-2025-N-6494. The agency’s conclusions are described in the Final Administrative Order (OTC000039) “Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information” which was issued 10 June 2026. The effective date of this final order is 9 August 2026 with an 18-month period of exclusivity per the regulations. A history of the process is available on the agency’s website. Please see the final administrative order for full details.
Highlighted Guidance Documents
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
This technical specifications document represents the FDA’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Forms FDA 3542a and FDA 3542: Questions and Answers
The FDA is announcing the availability of a draft guidance for industry titled “Forms FDA 3542a and FDA 3542: Questions and Answers.” This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542 and to assist applicants in preparing and submitting these forms to FDA.
DRAFT Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
Submit Comments by 07/24/2026
DRAFT Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers | FDA
Submit Comments by 08/03/2026
DRAFT Master Protocols for Drug and Biological Product Development
Submit Comments by 08/24/2026
DRAFT Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
Submit Comments by 09/22/2026
All Guidance Documents can be searched on the FDA’s website.
Federal Register
FR Vol 91, No 111 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus
Meetings
Date: June 23, 2026
Time: 1:00 p.m. – 2:30 p.m. ET
Location: Attend In Person or Virtual: via webcast
In Person: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503
Silver Spring, MD 20993
Date: June 24, 2026
Time: 1:00 p.m. – 2:00 p.m. ET
FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds
Date: August 25, 2026
Time: 10:00 a.m. – 4:30 p.m. ET
Location: Attend In Person or Virtual: via webcast
In Person: FDA White Oak Campus
10903 New Hampshire Avenue
Building 31, Room 1503
Silver Spring, MD 20993
Date: September 25, 2026
Time: 4:00 a.m. – 7:00 a.m. ET
FDA Websites of Interest
- Real-World Evidence Submissions to the Center for Drug Evaluation and Research
- Report on the State of Pharmaceutical Quality
- Drug Trials Snapshots
- Phase 1 Investigational New Drug (IND) Navigator
- FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose
- Real-World Evidence Submissions to the Center for Biologics Evaluation and Research
Posted in Drug and Device Corner, Drugs, Medical Devices.