RA/QA News Roll: Mid September 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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Here are some key items from the past couple of weeks.
π = Pharma, biologic, and biotech.
π = Medical device, medtech, diagnostics, and digital health.
FDA Guidances, Regulations, and Related Documents
A new Federal Register notice confirms that the FDA has begun supporting Version 4.0 of the Electronic Common Technical Document (eCTD). Initially, the agency will accept submissions in both eCTDv3.2.2 and eCTDv4.0 formats. Eventually, the FDA will transition to supporting only eCTDv4.0 submissions. π
The FDA has published a final guidance document on controlling nitrosamine impurities. Nitrosamines are carcinogenic contaminants for which international regulators have set exposure limits following recalls of major products. The FDA previously released two guidances on this topic: an August 2023 guidance establishing recommended acceptable intake limits for nitrosamine impurities in drugs and a September 2020 draft guidance on impurity control. The new final guidance updates the September 2020 draft, incorporating significant changes that reflect the evolving regulatory understanding of nitrosamine impurities over the past four years. Additionally, the FDA has updated approximately a dozen acceptable intake limits for nitrosamine impurities on its website. π
The FDA published an updated Bioresearch Monitoring Technical Conformance Guide. A comparison with the 2022 version shows that only a few email inbox addresses and guidance links have been updated. π
The FDA has published a new draft guidance document that incorporates voluntary patient preference information throughout a medical device's total product life cycle (TPLC). TPLC encompasses all stages, from product development to approval, marketing, and eventual phase-out. The guidance outlines how device sponsors can integrate patient inputs and preferences into various development activities, including clinical studies and product labeling. π
The FDA has released a revised guidance document on submitting amendments to ANDAs. The document, which was last updated in 2018, includes extensive changes throughout. π
The FDA has published a new Draft Strategy Document on Innovative Manufacturing Technologies, fulfilling requirements set by the Prescription Drug User Fee Act (PDUFA) VII goals letter. The document outlines an action plan that includes:
Updating the Emerging Technology Program Guidance by 2026.
Revising the process for the CBER Advanced Technologies Team (CATT) to streamline tracking and timely review of meeting requests, aiming to provide 206 efficiencies by November 2024.
Developing new guidance on "Approaches to Meeting CGMP Requirements for Distributed Manufacturing" by December 2024.
The document primarily summarizes workshops and details the FDAβs planned activities to enhance innovative manufacturing technologies. π
The FDA has published a new final guidance document on submitting regulatory applications for certain pharmaceutical products using the electronic Common Technical Document (eCTD) format. This guidance applies to specific human pharmaceutical product applications and related submissions using eCTD specifications. The guidance has been updated with new hyperlinks, several new sections, and the inclusion of the new eCTD 4.0 standard. π
FDA General
The FDA has released a new batch of medical device classification notices for the following devices, all classified as Class II with special controls: π
The FDA published a Federal Register notice announcing plans to conduct a survey of medical device executives to support pediatric medical device development efforts. Initially, the FDA intended to administer the survey through the Yale-Mayo Clinic Centers of Excellence in Regulatory Science and Innovation (CERSI). However, since the previous cohort of students trained on the surveyβs relevant issues has graduated, the FDA will now field the survey using professional staff at Yaleβs CERSI. π
The CDRH has announced that its Experiential Learning Programβs (ELP) Fall cohort is open for applications until October 7, 2024. Established in 2013, the ELP is designed to help CDRH staff gain a better understanding of the industries they regulate. π
The FDA released a new batch of briefing documents for its Gastrointestinal Drugs Advisory Committee meeting on September 13th. The meeting focused on Intercept Pharmaceuticalsβ OCALIVA, a drug that has already received accelerated approval for certain indications related to primary biliary cholangitis and is seeking conversion to full approval. According to Reuters, FDA reviewers have raised efficacy concerns that could jeopardize the drugβs conversion to full approval. π