Drug and Device June 2023

The FDA has published a new Guidance Document Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 which explains in great detail the GDUFA program user fee obligations. GDUFA III made slight changes to the user fee structure. (API facility fees changed from 7% to 6% and the GDUFA program fee changed from 35% to 36% of total revenue. Additionally the CMO facility fee has been decreased to 24% of the FDF fee, where it used to be 1/3) More importantly, the guidance explains clearly the circumstances under which the agency will hold a facility / applicant responsible for user fees. A facility will be held liable for user fees if the 2 criteria are met: referenced in an approved generic drug application and engaged in manufacturing or processing an API or FDF on 1 October or the first following business day. The guidance also articulates the fee required to be paid for an API not included by reference to a DMF, the (a)(3)(F) fee.

A recently issued Guidance Document for Cover Letter Attachments for Controlled Correspondences and ANDA Submissions includes templates in separate appendices for each of the relevant types of submissions. These Cover Letter attachments are check lists developed by the divisions that handle the specific submissions and are expected to improve the efficiency of triaging and assigning resources to keep the agency in line with GDUFA III commitments. The ‘attachment templates’ can either be used as a guide in preparing your cover letter, or they can be included with the cover letter in your submission. Do note, the attachments would be in addition to what has already been recommended for cover letters.

The FDA has been reaching out to registered medical device entities reminding them of the UDI labeling and GUDID reporting requirements. With the last of the enforcement compliance dates occurring in December 2022, all medical device labelers should have a UDI process in place. If you have questions on your requirements or need support with either UDI or the GUDID system, EAS is here as your regulatory partner to assist.

CDRH has announced that the Global Unique Device Identification Database (GUDID) public access system will begin releasing the Global Medical Deice Nomenclature (GMDN) term codes publicly on 14 August 2023. The agency recommends labelers review their current listings and ensure all fields are up to date and accurate. It is expected that by the end of July 2023, the GUDID Access Database will be completely current for all medical device labelers.

The agency is reminding relevant stakeholders to begin their transition to the Guidance Document Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) to ensure compliance by the end of 2024. Please see the website for more specific details.

Highlighted Guidance Documents

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act

This guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the FD&C Act. The drugs that this guidance covers are nonprescription drugs without approved new drug applications, which are governed by the provisions of section 505G (OTC monograph drugs).

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

The purpose of this guidance document is to provide an overview of the mechanisms available to submitters through which they can request feedback in writing or during a meeting with the Food and Drug Administration regarding potential or planned medical device IDE Exemption applications, PMA applications, HDE applications, De Novo requests, 510(k) Submissions, CLIA Amendments Waiver by Applications, Dual 510(k) and CLIA Waiver by Application Submissions, Accessory Classification Requests, and certain INDs and BLAs submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act).

Content of Premarket Submissions for Device Software Functions

This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the FD&C Act. The recommendations in this guidance are intended to facilitate FDA’s premarket review. This guidance document replaces FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005.

Migraine: Developing Drugs for Preventive Treatment

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the preventive treatment of migraine. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support approval of drugs for the preventive treatment of migraine.

CVM GFI #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter

This guidance is intended for sponsors of approved applications and abbreviated applications for new animal drugs containing medically important antimicrobials for use in non-food (companion), food-producing animals, or both, that are currently approved with over-the-counter marketing status.

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

FDA Websites of Interest

Report on the State of Pharmaceutical Quality

FDA and European Union Announce Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs

(MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests.

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

CDER’s ARC Program

FDA Issues Draft Guidance on Tattoo Inks