Drug and Device Corner December 2024

The FDA issued a final rule establishing requirements for a nonprescription drug product with an Additional Condition for Nonprescription Use (ACNU).

This new marketing pathway will allow the sale of a nonprescription drug product directly to a consumer once the user completes an ACNU demonstrating that the drug is appropriate and safe for that consumer. An example of an “additional condition” could be a questionnaire to determine if the drug product is right for the consumer.

The final rule is intended to increase options for pharmaceutical companies to develop and market nonprescription drug products and increase consumer access to appropriate, safe, and effective drug products.

This new rule does not impact nonprescription drug products marketed under an approved marketing application or over-the-counter monograph.

Please review Federal Register Vol. 89, No. 247 published on 26 December 2024 for full details. You can also read FDA’s webpage: 7 Things to Know About the Nonprescription Drug Product with an Additional Condition for Nonprescription Use Final Rule.

The Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products has been updated to finalize an FAQ section, with a few draft answers yet to be finalized. These draft questions are available for comment until 13 January 2025.

The FDA has announced their proposed rule to require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products in the Federal Register Vol. 89, No. 248 published 27 December 2024. Comments may be made to Docket Number FDA-2023-N-4225 by 27 March 2025.

Highlighted Guidance Documents

Global Unique Device Identification Database (GUDID) | FDA

This guidance document provides the FDA’s recommendations on the information necessary for labelers submitting data to GUDID. FDA has updated this document to reflect changes to the Global Medical Device Nomenclature (GMDN) field in GUDID. The option to use FDA Preferred Terms (FDA PT) Codes will be removed because FDA PT codes are no longer necessary since GMDN Terms are now available without a paid membership.

Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry | FDA

This guidance describes the electronic submission of certain data and information in standardized formats. This information is used by the Center for Drug Evaluation and Research in the planning of, and by FDA’s Office of Inspections and Investigations in the conduct of, BIMO inspections.

E11A Pediatric Extrapolation | FDA

The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides a comprehensive and systematic approach to pediatric extrapolation during drug development. Notably, the guidance discusses approaches to safety extrapolation and defining extrapolation as a continuum. The guidance also includes approaches to study designs and statistical methodologies, including modeling and simulation, for developing and implementing pediatric extrapolation. The guidance is intended to provide approaches that can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. The guidance replaces the draft guidance “E11A Pediatric Exploration” issued on August 29, 2022.

Accelerated Approval – Expedited Program for Serious Conditions | FDA

The purpose of this guidance is to provide information on FDA’s policies and procedures for accelerated approval as well as threshold criteria generally applicable to concluding that a drug is a candidate for accelerated approval.

DRAFT Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices | FDA

Submit Comments by 28 February 2025

DRAFT M15 General Principles for Model-Informed Drug Development | FDA

Submit Comments by 28 February 2025

DRAFT E6(R3) Good Clinical Practice: Annex 2 | FDA

Submit Comments by 28 February 2025

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