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Drug and Device Corner 2025 October

Oct 28, 2025 | Drug and Device Corner

Drug and Device

REMINDER: We are in the drug registration renewal and listing certification period, do schedule your renewal/certification prior to the 31 December 2025 deadline. Facilities that manufacture OTC monograph drugs are reminded that the data pulled for assessing FY2026 OMUFA user fees are based on current registrations. If you need assistance with your renewal submission, please reach out to Victoria Pankovich for support. 

Due to the U.S. government shut down, medical device renewals, updates and initial registrations are currently on hold. These submissions cannot be processed until the government reopens. EAS will keep you informed as the situation evolves.

FDA Announces New ANDA Prioritization Pilot to Support U.S. Generic Drug Manufacturing and Testing On 3 October 2025, the U.S. Food and Drug Administration announced a new pilot prioritization program aimed at building the domestic manufacture, R & D, and testing of generic drugs. The program will prioritize applications that qualify for the program (domestic establishments conducting the pivotal BE testing, finished dosage manufacturer located in the U.S., the API is supplied by a domestic facility). Review of these qualified applications will be faster to increase the drug supply being produced in the United States. The administration has positioned that domestically produced generic drugs are critical not only for public health but also to national security. The program hopes to incentivize US generic drug manufacturing and testing. Please see the website for full details.

EAS continues to see quite a number of Warning Letters issued to both pharmaceutical and medical device firms for cGMP observations. Our own Jeb Hunter will be presenting a complimentary webinar “Preparing for an FDA Inspection” on Tuesday 11 November 2025. Register for the webinar or reach out to EAS for support if you would like more information on FDA inspection preparedness.

Highlighted Guidance Documents 

Conducting Clinical Trials With Decentralized Elements
This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralized elements in clinical trials. Decentralized elements allow trial-related activities to occur remotely at locations convenient for trial participants. Decentralized elements can include, among other things, telehealth visits with trial personnel, in-home visits with remote trial personnel, or visits with local health care providers.

Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
The FDA is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.” This guidance is the third in a series of four methodological patient-focused drug development guidance documents that describe how stakeholders can submit patient experience and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making. This guidance finalizes the draft guidance of the same title issued on June 30, 2022.

Electronic Submission Template for Medical Device De Novo Requests | FDA
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.

DRAFT E20 Adaptive Designs for Clinical Trials | FDA
Submit Comments by 12/01/2025

DRAFT Malaria: Developing Drugs for Treatment | FDA
Submit Comments by 12/22/2025

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

Meetings

2025 17th Annual Public Workshop | Sentinel Initiative

Date: Thursday, November 6, 2025
Time: 9:00am – 3:00pm ET
Event Type: Workshop
Event Location: Virtual and In-Person (FDA White Oak Campus, Silver Spring, MD)

Visionary Standards: Advancing Sci & Reg in Generic Ophthalmic Products

Dates: Nov 19 – 20, 2025
Time: 8:30 am – 5:00 pm
Virtual ($0) and In Person ($350 registration)
The Universities at Shady Grove
9630 Gudelsky Drive
Rockville, MD 20850

Individualized Therapies on the RISE

Date: November 20, 2025
Time: 9:00AM–5:00PM
Virtual and In Person
National Press Club
529 14th St NW
Washington, DC 20045, United States

Quality and Regulatory Predictability: Shaping USP Standards

Date: December 11, 2025
Time: 9:00 a.m. – 10:30 a.m. ET

FDA Websites of Interest

Posted in Drug and Device Corner.