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We will be entering the establishment renewal and product listing certification period soon. As your regulatory support partner, EAS is here for any questions you may have.  If you wish for us to handle the annual requirements, please email Victoria Pankovich to get on the schedule. The annual renewal and certification period runs from 1 October – 31 December.

The FDA has announced FY2024 GDUFA user fee rates in the Federal Register Vol 88, No. 144.  Notable fees: DMF $94,682; Domestic API facility $40,464; Foreign API facility $55,464; Domestic FDF facility $220,427; Foreign FDF facility $235,427; Domestic CMO $52,902; Foreign CMO $67,902.  The GDUFA website has full details.

EAS has noticed an uptick in Warning Letters with the subject “CGMP/Finished Pharmaceuticals/Adulterated”.  If you have concerns about the cGMP compliance of your drug facility, please contact EAS to discuss audit options.  We would be happy to prepare a proposal.

The agency is asking all applicants to begin using the updated versions of FDA forms 356h (Application to market a new or abbreviated new drug or biologic for human use) and 1571 (Investigational New Drug Application).  Changes to the forms are articulated on the FDA’s New and Updated FDA Forms website which also includes links to the updated documents.

The Federal Register Vol 88, No 144 announced FY2024 PDUFA rates.  The FDA also sent direct emails to firms with PDUFA user fee eligible products. For more information regarding the FY 2024 fee rates, please see the PDUFA website.

As previously shared, the FDA has announced FY2024 user fees under the Medical Device User Fee Amendments (MDUFA).  The annual establishment registration fee of $6,493 for medical device facilities will be due between October – December 2023 during the renewal period.  Do remember to factor in processing time for the agency (2-3 days) and the holiday disruptions that happen during the renewal period.  All user fees can be reviewed on the FDA website.

Highlighted Guidance Documents

Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities

This guidance provides applicants and manufacturers of drugs, including prescription and over-the-counter drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential of NDSRIs that could be present in drug products and recommends acceptable intake limits for NDSRIs. This guidance provides a recommended methodology for acceptable intake determination that uses structural features of NDSRIs to generate a predicted carcinogenic potency categorization and corresponding recommended AI limit that manufacturers and applicants can apply, in the absence of other FDA-recommended AI limits, in their evaluation of potential impurities in their drug products.

Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

The purpose of this draft guidance is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products, when appropriate, in the postmarketing setting in historically under-represented patient populations in clinical trials.

Draft Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products

This guidance provides recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA.

Off-The-Shelf Software Use in Medical Devices

This guidance document provides information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off-the-shelf software used in a medical device. This guidance describes information that would be typically generated and documented during software development, verification, and validation.

PDUFA Waivers, Reductions, and Refunds for Fixed- Combinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR

This draft guidance describes circumstances in which an applicant may be eligible for a barrier-to-innovation waiver under the Prescription Drug User Fee Act for certain new drug applications for single-entity antiretroviral and fixed-combination ARV drug products for the treatment or prevention of human immunodeficiency virus-1 (HIV-1 or HIV).

Assessing User Fees Under the Biosimilar User Fee Amendments of 2022

This guidance describes the types of user fees authorized by BsUFA III, how FDA determines which products are subject to a fee, and FDA’s policies regarding exceptions and waivers.  This guidance also describes the process for submitting payments to FDA and the consequences for failing to pay BsUFA fees, and the process for requesting reconsideration if FDA denies a request for a waiver or return of user fees.

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


Understanding FDA Inspections and Data

Date: Wednesday, September 6, 2023
Time: 1:00 PM – 3:00 PM ET

Public Meeting: Modernizing Recalls of FDA-Regulated Commodities

Date: Friday, September 29, 2023
Time: 9:00 AM – 5:00 PM ET

Advancing Generic Drug Development: Translating Science to Approval 2023

Dates: September 13 – 14, 2023
Day1: Wed, Sep 13 9:00 AM – 5:00 PM ET
Day2: Thu, Sep 14 9:00 AM – 5:00 PM ET

Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards

Day 2: Tuesday, Nov 7 9:00 AM – 12:00 PM ET
(Completion of 2 part series which began April 4, 2023)

FDA Websites of Interest

Non-FDA Website of Interest, European Commission

Posted in Drug and Device Corner, Drugs, Medical Devices.