Drug and Device Corner 2025 September

REMINDER: The drug and medical device establishment registration renewal and listing certification period begins 1 October 2025. EAS is here to assist our clients with this process, do not hesitate to reach out if you need support.

The agency has published their final guidance document “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications”. During the COVID-19 pandemic when in person inspections for drug application marketing approval was not possible, the FDA expanded its use of alternative tools under a risk-based approach. This guidance document articulates the processes the agency has determined were shown to be effective in assessing manufacturing facilities named in drug applications. FDA intends to continue risk-based use of these alternative tools during normal operations. Full details can be found in the final guidance.

The FDA announced that they will be releasing Complete Response Letters in real-time. At the time of this announcement the agency posted a batch of 89 previously unpublished CR Letters issued to either pending or withdrawn applications. Henceforth, the agency will be publicly publishing CRLs as they are issued, in addition to their previously standard policy of releasing the CRLs with application approval. FDA will also periodically release batches of CRLs issued to withdrawn or abandoned applications. Sections of these CRLs will be redacted, however, company names will not be one of those fields. This policy, considered highly transparent for the public interest, is intended to assist applicants with information on missteps and support efficiency in the application process.

FDA has launched a Green List import alert which will identify GLP-1 APIs that are manufactured / processed at FDA inspected or evaluated facilities. These establishments are those that appear to be compliant with applicable standards and regulations. The green list is designed to keep illegal GLP-1 active ingredients manufactured in foreign facilities from entering the U.S.

The FDA launched a Real-Time Adverse Event Reporting Dashboard for Cosmetic Products dedicated exclusively to reports of cosmetic product adverse events. This includes serious adverse event reports submitted by Responsible Persons, as well as voluntary reports submitted by the public.

Highlighted Guidance Documents

Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry

This guidance describes the Agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under section 351(a) of the Public Health Service Act. Additionally, this guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls portion of a marketing application for a proposed product submitted under section 351(k) of the PHS Act. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product” issued on April 30, 2015.

E6(R3) Good Clinical Practice (GCP)

The Food and Drug Administration is announcing the availability of a final guidance for industry entitled “E6(R3) Good Clinical Practice.” This revision incorporates flexible, risk-based approaches and embraces innovations in trial design, conduct, and technology.

DRAFT Development of Non-Opioid Analgesics for Chronic Pain
Submit Comments by 11/10/2025

DRAFT Disseminated Coccidioidomycosis: Developing Drugs for Treatment
Submit Comments by 11/17/2025

DRAFT Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment
Submit Comments by 11/17/2025

DRAFT Erosive Esophagitis: Developing Drugs for Treatment
Submit Comments by 11/17/2025

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

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