Drug and Device November 2024 - EAS Consulting Group

This is the final reminder that we are in the annual medical device facility renewal, drug establishment renewal, and listing certification period. All renewals and certifications must be completed by 31 December 2024. If you need help with your submissions, please reach out to EAS for support.

There were quite a few Warning Letters published in November issued by CDER for sightings related to CGMP/Finished Pharmaceuticals/Adulterated. EAS can provide a cGMP audit of your facility to assist in preparedness for an FDA inspection. Please contact EAS for further information.

Amending Over-the-Counter Monograph M012: Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use. The FDA has issued a Proposed Administrative Order OTC 000036 (Amending OTC M012) to remove orally administered phenylephrine hydrochloride and phenylephrine bitartrate in an effervescent dosage as a nasal decongestant active ingredient. Following the OMUFA process the agency has published their proposed administrative order for public review and comment. Comments may be submitted to docket number FDA-2024-N-4734 by 7 May 2025. The Federal Register Vol 89, No. 217 notice has further details on the comment process.

Federal Register Vol 89, No. 212 Reauthorization of the Over-The-Counter Monograph Drug User Fee Program; Public Meeting; Request for Comments notice was published 1 November 2024 with details on how to weigh in on the FDA’s proposed recommendations for reauthorization of OMUFA. The November meeting Presentation can be reviewed online. Comments must be submitted to Docket (FDA-2023-N-3575 by 20 December 2024.

Highlighted Guidance Documents:

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms

This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

This guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the review of 510(k) submissions and EUA requests by third party review organizations. This guidance provides updated recommendations on the 510(k) Third Party Review Program and supersedes the “510(k) Third Party Review Program” guidance.

Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions

This guidance document provides the FDA’s recommendations on information to support premarket submissions for orthopedic non-spinal bone plates, screws, and washers. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of orthopedic non-spinal bone plate, screw, and washer submissions.

Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway

This guidance provides performance criteria for non-spinal metallic bone screws and their associated washers in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for non-spinal metallic bone screws and washers will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. The recommendations are intended to promote consistency and facilitate efficient review of orthopedic non-spinal metallic bone screws and washers.

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