Drug and Device July 2024

FDA has sent notices to drug establishment registrants reminding OTC hand sanitizer manufacturers who entered the market solely to provide hand sanitizer during the COVID-19 public health emergency, that beginning FY2025 OMUFA facility user fees will become mandatory. The FDA had previously announced that drug facilities that first registered during the COVID-19 pandemic solely for the purpose of providing hand sanitizer products during the public health emergency were not identified as facilities subject to OMUFA facility user fees for a certain time period. That period will end 30 December 2024. Consequently, any OTC hand sanitizer drug facilities that remain registered with the FDA beyond 30 December 2024 will be liable for OMUFA facility user fees going forward. De-listing of drug product NDCs and de-registration of a drug establishment must be submitted no later than 12:00 a.m. EST on 31 December 24 to avoid the FY2025 user fee. If you have questions or need further information, please reach out to EAS for support.

EAS is continuing to see an increased number of Warning Letters citing drug establishment GMP deficiencies published on the public database. The US FDA considers products to be adulterated if methods, facilities or controls for manufacturing, processing, packing, or holding do not comply with cGMP regulations. EAS can provide a GMP gap assessment of your facility to identify any areas of your operation that could use improvement. If you would like to discuss this service, please reach out to Victoria Pankovich or Lisa El-Shall for further information.

Highlighted Guidance Documents

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder

This guidance provides recommendations for the design of pivotal clinical studies for devices intended to treat opioid use disorder and used to support marketing submissions. These recommendations are applicable to the design and development of clinical studies to provide a reasonable assurance of safety and effectiveness for a device intended to treat OUD. OUD device studies designed using the recommendations set out in this guidance may advance the treatment of OUD by providing scientific evidence that aids FDA in determining whether there is a reasonable assurance that a device intended to treat OUD is safe and effective.

Application User Fees for Combination Products

This document provides guidance to industry and FDA staff on application user fees for combination products as defined under 21 CFR 3.2(e). Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. The guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. The document also addresses how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts

M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
DRAFT GUIDANCE
Submit Comments by 09/03/2024

Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products
DRAFT GUIDANCE
Submit Comments by 09/09/2024

Dental Composite Resin Devices – Premarket Notification (510(k)) Submissions
DRAFT GUIDANCE
Submit Comments by 09/10/2024

Dental Curing Lights – Premarket Notification (510(k)) Submissions
DRAFT GUIDANCE
Submit Comments by 09/10/2024

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers
DRAFT GUIDANCE
Submit Comments by 09/23/2024

Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers
DRAFT GUIDANCE
Comments may be made to Docket Number: FDA-2014-D-0447

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

Federal Register

FR Vol. 89, No. 143, Biosimilar Product Development Guidance; Establishment of a Public Docket; Request for Information and Comments

Meetings

Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A
Date: August 7, 2024
Time: 2:00 PM – 3:00 PM ET

Webinar – In Vitro Diagnostic Products (IVDs) – MDR Requirements, Correction and Removal Reporting Requirements, and Quality System Complaint Requirements – 08/22/2024
Date: August 22, 2024
Time: 1:00 PM – 2:30 PM ET

FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
Date: September 4, 2024
Time: 11:00 AM – 3:00 PM ET

Electronic Drug Registration and Listing (eDRLS) Using CDER Direct
Date: September 12, 2024
Time: 8:45 AM – 4:45 PM ET

Advancing Generic Drug Development: Translating Science to Approval
Date: September 24 – 25, 2024
Day1: Tue, Sep 24 8:30 AM – 4:30 PM ET
Day2: Wed, Sep 25 8:30 AM – 4:30 PM ET

Public Workshop –Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices
Date: November 6, 2024
Time: 8:00 AM – 5:00 PM ET

FDA Websites of Interest

Laboratory Developed Tests: FAQs

FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients