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.

💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.

FDA Guidances, Regulations, and Related Documents

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• 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. 💊

• 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guidance establishing recommended acceptable intake limits for nitrosamine impurities in drugs and a September 2020 draft guidance on impurity control.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. 💊
  

  Guidance Breakdown: FDA Revises Its Final Guidance on Nitrosamine Impurities

• 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. 💊

• The FDA has published a new draft guidance document that incorporates voluntary patient preference information throughout a medical device's total product life cycle (TPLC).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. 💉

• 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. 💊
  

  Guidance Breakdown: FDA Revises Its 2018 Guidance on Submitting Amendments to ANDAs

• 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 FDA’s planned activities to enhance innovative manufacturing technologies. 💊

• 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. 💊

FDA General

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• Michelle Tarver, the acting Director of the CDRH, and Jeff Shuren, the former CDRH Director, will speak at an upcoming Town Hall meeting organized by Pathway for Patient Health. 💉

• The FDA has released a new batch of medical device classification notices for the following devices, all classified as Class II with special controls: 💉

  1. Spineology Interbody Fusion System: Intervertebral Body Graft Containment Devices

  2. Signifier Medical Technologies' eXciteOSA: Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea

  3. Q30 Sports Science's Q-Collar: External Compression Device for Internal Jugular Vein Compression

  4. Akili Interactive Labs' Endeavor Rx: Digital Therapy Device for Attention Deficit Hyperactivity Disorder

• The FDA has published a new batch of FOIA logs detailing the requests made to the agency and the responses provided during August. 💊 💉

• 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 survey’s relevant issues has graduated, the FDA will now field the survey using professional staff at Yale’s CERSI. 💉

• An analysis by FDA Law Blog indicates that CDRH is catching up on posting previously long-outdated De Novo decision summaries, with 15 new summaries published in a week. 💉

• The CDRH has announced that its Experiential Learning Program’s (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. 💉

• The Alliance for a Stronger FDA announced that it will host FDA Commissioner Robert Califf for a fireside chat on September 27. 💊 💉

• In an interview, Rajanikant Madabushi, the lead for the Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE), described the purpose and goals of the new center. 💊

• The FDA released a new batch of briefing documents for its Gastrointestinal Drugs Advisory Committee meeting on September 13th. The meeting focused on Intercept Pharmaceuticals’ 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 drug’s conversion to full approval. 💊