RA/QA News Roll: Mid March 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Weβve added emojis to our links to denote pharma/biologic items (π) from device/diagnostic/digital health items (π) when thereβs a clear relevance to only one sector.
Here are some key items from the past couple of weeks.
FDA Guidances and Related Documents
The FDA has recently published two harmonized guidelines developed by the International Council for Harmonization (ICH), a group of which the FDA is a founding member. These guidelines, Q2 and Q14, focus on drug quality, particularly developing and validating analytical procedures essential for ensuring drug quality and consistency. π
The FDA has released a new draft guidance document on requests for feedback and its Q-submission program. This program enables sponsors to request feedback on medical device programs under development. π
The CDER has issued a revised Manual of Policies and Procedures concerning Good Review Practices for drugs and biologics granted breakthrough therapy designation. This update aims to align with the Office of New Drugs' organizational structure, the latest user fee program commitments, and other best practices. π
The FDA has issued a new draft guidance document outlining how sponsors of medical devices that produce tissue heating or cooling can evaluate their devices' thermal effects. Given that applying hot or cold temperatures to human tissues can potentially lead to damage or other adverse events, the FDA's guidance aims to mitigate these effects through more rigorous testing protocols. π
A duo of new documents outlines negotiations between the nonprescription drugs industry and the FDA regarding reauthorizing the OTC Monograph User Fee Act. Among the topics discussed are moving registration dates for facility fee payments, a "product quality enhancement proposal" aimed at improving the FDA's understanding of OTC quality risks, developing validated test methods for OTC monograph products, introducing a new meeting type (Type W), cataloging older paper-based monograph documents, and reforms to provide industry with greater certainty around timeframes for notifications for Advisory Committees. π
The FDA has issued a new technical amendment to its device regulations, incorporating predetermined change control plans (PCCPs) to exempt them from the requirement of submitting premarketing applications for approval or clearance. This exemption applies if the change is consistent with a PCCP approved or cleared by the FDA. PCCPs are utilized for various device types and are designed to outline a plan for accommodating post-marketing changes without necessitating additional review by the FDA. π
The FDA has released a new draft guidance document outlining the procedure for companies with branded, generic, or over-the-counter drugs to inform the agency about minor labeling changes made as part of an annual update. These changes might involve alterations such as modifying the color of the drug facts label or relocating a statement on tampered evidence from the drug facts label to the outer carton. π
After an extensive review, the White House's Office of Information and Regulatory Affairs (OIRA) has cleared an FDA-proposed rule addressing "drug products or categories of drug products that present demonstrable difficulties for compounding." This rule has been under review since August 2023. π
The FDA has completed a new draft guidance, seemingly aimed at preparing for future pandemics or public health emergencies. Titled "Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response Prior to a Declaration under Section 564," the guidance has been sent to the White House for review. π
The FDA has finalized a highly anticipated guidance on the New Dietary Ingredient Notification (NDIN) process, focusing on the submission procedures and timeframes. The FDA utilizes this process to assess the safety and marketing claims of dietary supplement products that were not marketed before the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994. In 2016, the FDA issued a comprehensive guidance on the NDIN process, which was extensively criticized by the industry due to its length (102 pages). In response, the FDA is now planning to release a series of smaller, more focused guidance documents targeting specific aspects of the NDIN process. π
The FDA is proposing several changes to its New Drug Application forms to accommodate recent legislative requirements, such as the CREATES Act, and to enable the submission of additional information. π
Read our analysis here:The FDA has released a new draft guidance document concerning post-approval safety data, focusing on the definitions and standards for managing and reporting individual case safety reports (ICSRs). This document represents a revision of the existing ICH guideline known as E2D(R1). π
FDA General
The full FDAβs Rare Disease Day 2024 is available to watch on YouTube. While the event primarily served to educate patients and advocates, certain programmatic updates provided a glimpse into ongoing activities and priorities for the agency, including pilot programs like the START Pilot program (i.e., Operation Warp Speed for rare diseases). π
The FDA has issued a grant notice proposing funding for research on the utilization of digital health technologies in clinical investigations to aid in developing and evaluating drugs and biologics. The funding could support various projects, including those comparing digital measurements to traditional ones or developing tools capable of capturing early signs of chronic diseases such as dementia. π
The FDA is seeking sources with the capability to develop and conduct a "three-dimensional (3D) correlative imaging, quantitative image analysis of Critical Quality Attributes (CQAs), and image-based in silico release modeling of complex drug products." This initiative aims to facilitate the review and testing of generic versions of various drug products, including long-acting implants, microspheres, in situ forming depots, locally-acting topical formulations (dermal, vaginal, rectal), transdermal patches, ophthalmic products, and combination products such as inhalers. π
In January 2024, the FDA's generic drug division, the Office of Generic Drugs, approved 56 new generic drug products. Additionally, tentative approvals were granted to another 17 products, which cannot be marketed until the patent or exclusivity protections of the original drug expire. π
Governing
Senator Tim Scott (R-S.C.) and Buddy Carter (R-Ga.) have written to the FDA concerning its recent draft guidance document on advanced manufacturing technologies, which they assert "falls far short of adhering to Congress's intent." They highlight that currently, companies may not be able to "cross-reference information about AMT-designated technologies." π