Drug and Device Corner June 2025 - EAS Consulting Group

The FDA has released two proposed administrative orders for requesting minor dosage form changes to certain OTC monograph drugs. These administrative orders are open for comment.

Proposed Administrative Order OTC000038

If finalized, this proposed order will specify requirements for industry to make minor dosage form changes to certain OTC monograph drugs. The changes covered would be from tablets and capsules to chewable tablets, orally disintegrating tablets, or films. The agency believes these changes would foster innovation without the need for an OMOR submission and related final order amending an applicable OTC monograph.

Comments may be made by 3 October 2025 to Docket FDA-2025-N-1360

Proposed Administrative Order OTC000037

If finalized, this proposed order will establish requirements for the packaging of certain OTC monograph drugs in ODT or film dosage forms.

Comments may be made by 4 August 2025 to Docket FDA-2025-N-1359

For answers to frequently asked questions about OTC monograph drugs and the administrative order process, visit the OTC Monographs @ FDA website.

On 17 June 2025, the agency announced the FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. The CNPV program pilot phase will award a limited number of vouchers to companies that fit the defined criteria, shortening the application review time from 10-12 months to 1-2 months following final application submission. The program intends to utilize a one day “tumor board style” meeting to convene experts from FDA offices for a “team-based review”. This new program would require companies to submit their CMC sections and draft labeling at least 60 days prior to the final application. Vouchers must be used within 2 years from receipt. The program will not be applicable to devices or drug-device combination applications. Information on how to apply for the vouchers is still pending. The program will not replace or affect other expedited paths, but could be used in conjunction. For further details, please see the FDA announcement.

FDA CDER has distributed its first edition of “What is New in Regulatory Science”, a quarterly newsletter by the Office of Translational Sciences (OTS) in collaboration with the Office of Communications within CDER. You may follow this link to sign up to receive future issues.

Highlighted Guidance Documents:

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions

This guidance describes the facility information to be submitted in a pre-submission facility correspondence (PFC) and how FDA will use this information to set a review goal for a priority abbreviated new drug application (ANDA). This guidance incorporates a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to reauthorization of the Generic Drug User Fee Amendments and as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027”. This guidance finalizes for implementation the draft guidance of the same title issued on December 5, 2022.

Post-Warning Letter Meetings Under GDUFA

This guidance provides information on the implementation of the Post-Warning Letter Meeting process for certain drug manufacturing facilities, a program enhancement agreed upon by the Agency and industry as part of the negotiations relating to the reauthorization of the Generic Drug User Fee Amendments, as described in “GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023–2027”. Specifically, this guidance describes the process detailed in the GDUFA III commitment letter for how an eligible facility may request a Post-Warning Letter Meeting with FDA regarding the facility’s ongoing remediation efforts to address current good manufacturing practice deficiencies described in a warning letter, how to prepare and submit a complete meeting package, and how FDA intends to conduct the Post-Warning Letter Meeting.

DRAFT: Replacing Color Additives in Approved or Marketed Drug Products

Submit Comments by 07/29/2025

DRAFT: Draft Guidance: Recommendations for Complying With OTC Monograph Procedure for Minor Changes C001

Submit Comments by 10/03/2025

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