We are 5 months out from the UDI / GUDID enforcement date of 22 September 2022 for Class I and unclassified devices, are your processes in place? Do you know what requirements are applicable to your operation? Helpful information can be found on FDA’s webpage GUDID Guidance, and in the Guidance Document titled: Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices. As your regulatory partner, EAS is here to support any needs that may arise.
Reminder that hand sanitizer drug products manufactured per the now withdrawn temporary guidance documents, should no longer be marketed or distributed. Per Federal Register Vol 86, No. 195 these products were to leave the market 31 Mar 2022. NDC drug listings for these products should also have been discontinued.
Guidance Documents of Interest
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs
This guidance pertains to submissions of promotional materials for human prescription drugs to the FDA made by manufacturers, packers, and distributors, whether the applicant or an entity acting on behalf of the applicant. Specifically, this guidance pertains to submissions made to the Office of Prescription Drug Promotion in the Center for Drug Evaluation and Research and the Advertising and Promotional Labeling Branch in the Center for Biologics Evaluation and Research.
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4
This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in 21 CFR part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the FD and C Act without an approved application under section 505 (commonly referred to as over-the-counter monograph drugs).
All Guidance Documents can be searched on the FDA’s website.
FR Vol. 87, No. 55, Docket No. FDA–2022–N–0236: Prioritizing the Addition of Maximum Daily Exposure Information and Removing Dosage Form Information From the Inactive Ingredient Database; Establishment of a Public Docket; Request for Comments. Comments may be made by 21 June 2022.
Quality Management Maturity Workshop
Date: May 24 – 25, 2022
Day1: Tue, May 24 / 1:00 PM – 4:00 PM ET
Day2: Wed, May 25 / 1:00 PM – 4:00 PM ET
FY 2022 Generic Drug Science and Research Initiatives Public Workshop
Date: May 9 – 10, 2022
Day1: Mon, May 9 / 8:00 AM – 4:30 PM ET
Day2: Tue, May 10 / 8:00 AM – 5:00 PM ET
FDA Websites of Interest
The FDA recently published their Manual of Policies and Procedures 5240.10, “Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products for Generic Drug Development Purposes.” This MAPP articulates the process to classify which approved new drug products would be considered complex for generic drug development purposes.
In another announcement the FDA publicized their proposed rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers Comments may be made to Docket No. FDA-2020-N-1663 by 6 June 2022. Further details on the proposed rule can be obtained on the FDA Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers SBIA webinar website.
Posted in Drug and Device Corner, Drugs, Medical Devices.