(571) 447-5500

Reminder that December is the deadline for the establishment registration and product listing renewal period. Kindly note the FDA has tightened up their validation process for drug listings. Although repack / relabeled listings have been submitted in the past without source NDC identification, this is no longer possible. Source NDCs must be included with all repack / relabel NDC listings. Also note, the FDA is now verifying business processes of all identified establishments in NDC listings. This could potentially slow down certification or updating of an NDC listing. Contact Victoria Pankovich, vpankovich@easconsultinggroup.com if you would like EAS to handle your registration renewal and / or your NDC listing required updates or certification

For those that have not already submitted their CARES Act reporting for FY2020 and FY2021, do note per the regulation these reports are due. Although the FDA proposed dates for submission of these reports were non-binding, the reports themselves are indeed required. If you need assistance with the process, please contact EAS for support.

The FDA has published a new batch of product-specific guidances. This recent batch of 49 PSGs includes: 29 new and 22 revised PSGs; 32 PSGs for products with no approved ANDAs (including 20 complex products); 28 PSGs for complex products (15 new and 13 revised PSGs); 11 new PSGs for complex products with no approved ANDAs and PSGs for products used for treatment of breast cancer, osteoarthritis pain, Duchenne Muscular Dystrophy, and other conditions

Guidance Documents of Interest

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program

This guidance describes the types of OMUFA fees, the due dates for fee payment, and the exceptions to certain fees. In addition, this guidance describes the process for submitting fee payments to FDA, the consequences for failing to pay the required fees, and the process for submitting refund requests or disputing FDA’s assessment of OMUFA fees.

Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents

FDA is issuing this guidance to clarify our approach for referencing the terms “device” and “counterfeit device” in FDA documents. For many years, the definition of “device” has been codified at section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Upon the enactment of the Safeguarding Therapeutics Act in January 2021, the definition of device was redesignated to section 201(h)(1) of the FD&C Act, and the new term “counterfeit device” and its definition were designated at section 201(h)(2) of the FD&C Act.

Sameness Evaluations in an ANDA — Active Ingredients

Not for implementation. Contains non-binding recommendations. This guidance is being distributed for comment purposes only.

This guidance is intended to assist applicants preparing an abbreviated new drug application by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug as required under section 505(j)(2)(A)(ii) of the FD&C Act and FDA’s regulations in 21 CFR 314.94(a)(5).

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

Federal Register

FR Vol. 87, No. 220 Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use; Request for Comments

FR Vol. 87, No. 209 Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement


Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
Date: November 30, 2022
Time: 8:00 AM – 4:30 PM ET

Public Workshop – Appropriate Use of Consensus Standards
Date: December 7, 2022
Time: 1:00 PM – 3:00 PM ET

The Drug Supply Chain Security Act (DSCSA) Implementation and Readiness Efforts for 2023
Dates: December 7 – 8, 2022
Day1: Wed, Dec 7 10:00 AM – 3:00 PM ET
Day2: Thu, Dec 8 10:00 AM – 3:00 PM ET

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