The FDA Group

The FDA Group’s Insider Newsletter delivers regulatory and compliance news and highly-actionable analysis from former FDA staff and experienced life science consultants working in the FDA-regulated industries, right to your inbox. It's an efficient way to keep up on news and other happenings at the FDA seen through the lens of those who’ve worked with—and within—the agency. New analysis issues arrive each month along with biweekly RA/QA news issues. Why subscribe? As a paid subscriber, you get access to each issue in full, along with downloadable slide decks you can use any way you’d like. RA/QA teams get tons of value from their paid subscriptions. It helps you: ? Quickly collect relevant industry news that impacts your role and company. ? Save time analyzing regulatory actions so you can act on them thoughtfully. ? Save time presenting industry updates to colleagues and leaders. ? Get consultant-level perspectives you won’t find elsewhere. Many subscribers simply?expense?this newsletter to their team’s learning and development budget. ?? Subscribe now and join 3,000+ life science professionals getting exclusive news and insights right in their inboxes: https://lnkd.in/dj6NpA6k

The FDA just posted final guidance introducing a transitional enforcement policy for ethylene oxide (EtO) sterilization facility changes affecting Class III medical devices. The guidance emerges from a critical context: the EPA published a final rule in April 2024 that revised emission standards for EtO sterilization facilities, requiring many facilities to install new controls or modify their operations. EtO sterilization is used to sterilize about 50% of devices requiring sterilization in the US. The policy aims to prevent potential medical device shortages during this transition period by providing a framework for the FDA to evaluate, on a case-by-case basis, whether they will exercise enforcement discretion regarding sterilization facility changes before formal PMA or HDE supplement approval. A few key elements of the policy: 1/ Applies only to Class III devices with approved PMAs or HDEs that are single-use devices provided sterile + sterilized using EtO (either fixed chamber or flexible bag). 2/ Does not apply to: - Other sterilization methods - Changes in sterilant type - Combo products - Reusable or non-sterile devices - 510(k) cleared devices - Devices licensed under Public Health Service Act 3/ Manufacturers submit informal notification to FDA including: - Device/product details and PMA/HDE numbers - Current and proposed sterilization facility information - Timeline for implementation - Summary of any sterilization process changes - Signed affirmation of no other device changes 4/ FDA then evaluates notifications case-by-case considering: - Potential supply disruption risks - Facility compliance history - Quality system standards 5/ If FDA exercises enforcement discretion, the manufacturer can implement change before supplement approval. They must submit formal PMA/HDE supplement within 120 days and must complete validation before distribution FDA conducts an expedited review of the supplement. 6/ The policy is anticipated to last 3 years based on EPA compliance deadlines. FDA may revise, extend, or replace the policy as needed. 7/ In terms of inspection requirements, pre-approval inspections are generally not required if a site has a good compliance history. FDA may conduct post-approval inspections as needed. ——— A few recommendations here: ?? First, determine if this policy applies to your Class III device. ?? Submit informal notification to FDA at [email protected] with device details, sterilization facility information, and timeline. ?? If FDA grants enforcement discretion, proceed with: - Process validation at the new site - Submit formal PMA/HDE supplement within 120 days - Continue preparation for potential FDA inspection ?? Maintain documentation showing no changes to device design, specifications, materials, or sterilization parameters beyond the facility change. #eto #fda

Looking for some practical ways to build a passionate life science team? We're excited to announce that our own Nicholas Capman will be featured in an upcoming Career Catalyst Circle session with the wonderful Jennifer Mascioli-Tudor, MBA, CQA. Join Nick and Jennifer on Tuesday, December 17 for an insightful discussion on entrepreneurial leadership in life sciences. Nick will share his playbook in guiding organizations through critical product lifecycle stages — from clinical development to commercialization, covering things like: - Building and maintaining high-performing teams - Fostering innovation within Quality Assurance, Regulatory Affairs, and Clinical Operations - Creating sustainable employee engagement strategies - Developing entrepreneurial thinking in corporate environments The session is totally free — part of the Career Catalyst Circle series — a community dedicated to professional growth and meaningful industry connections. Learn more and register via LinkedIn to receive the Zoom link: https://lnkd.in/gQ8yzRSy

Need some practical guidance on implementing AI in clinical trials and regulatory operations? We recently sat down with Keith Parent CEO of Court Square Group and RegDocs365, to get a frontline look at how life science companies can effectively adopt AI while maintaining compliance. With 30 years of experience managing infrastructure for both big pharma and small biotech, Keith shares invaluable insights on starting small and scaling intelligently. Keith sheds light on: - How to begin with "low-hanging fruit" and build momentum - Protecting IP while leveraging LLMs - Real-world applications in TMF management and regulatory correspondence - Scaling solutions from large pharma to smaller companies - Maintaining human oversight in AI implementations Watch the first few minutes below and catch the full conversation on your preferred platform: ? YouTube: https://lnkd.in/gyS5BUFe ? Apple Podcasts: https://lnkd.in/dtUwnXr ? Spotify: https://lnkd.in/gDNFqsmr ? Substack: https://lnkd.in/g3tyAX_3 ? Web + Others: https://lnkd.in/gHcBSVYp #ai #lifesciences #clinicaltrials #regulatoryaffairs #pharma #biotech #qualityassurance #tmf #trialmasterfile

On Tuesday, the FDA posted a warning letter to a Chinese drugmaker after management hindered an inspection from March 18 to 22 at the company’s site in the Xiqing District in Tianjin. Read the full warning letter: https://lnkd.in/g3PgG4iN - The company removed information from translated manufacturing records and refused to let agency inspectors take photos during a facility visit. Company staff informed the FDA investigators they concealed information after “top management” told them to “protect” certain data, which “significantly hindered” the inspection, according to the letter. - When investigators requested historical corrective action records from 2016-2024, the facility provided only 2024 data. - Management also blocked FDA investigators from photographing visibly dirty filling machines and denied access to certain manufacturing areas entirely. - The machines used for U.S.-bound products were found in disrepair, with one unit missing screws and having a broken motor housing panel, while another lacked a proper bowl cover and was held together with degraded bands. Despite being tagged as "clean," both machines showed visible residue contamination. - The facility's laboratory controls were also found deficient, particularly regarding stability testing. The company failed to employ stability-indicating analytical methods and had not conducted forced degradation studies to identify potential degradation products — raising significant questions about the validity of their product stability data and shelf-life determinations. - Further, the company lacked proper written instructions for producing its OTC products due to the withholding of information. It manufactures various drugs, including treatments for burns and scalds, ointments for diabetic patients, tissue regeneration products, and eczema treatments. —— The core lesson from this warning letter is unambiguous: attempting to limit or restrict an FDA inspection in any way is a serious violation that can result in immediate and severe consequences, regardless of the underlying quality of manufacturing operations. Even seemingly protective actions like redacting "proprietary" information, limiting photography, or restricting access to certain areas are considered forms of inspection refusal under Section 501(j) of the FD&C Act. The FDA views partial cooperation the same as refusal. Companies must be prepared to provide unrestricted access to records, areas, and processes, including allowing photography and providing unredacted documents. ——— Want to stay out of our warning letter breakdowns? Contact us to access our global network of 2,500+ consultants, 225+ former FDA. We run audits, mock inspections, and remediation for 17 of the top 25 life science firms. #fda

On Monday, the FDA released new draft guidance to help drugmakers navigate the development and submission process for new cell and gene therapies, covering pre-IND meetings, IND quality submissions, pre-BLA meetings, and long-term safety monitoring. The 40-page Q&A document, part of the FDA’s user fee commitments, consolidates common questions addressed to the Office of Therapeutic Products (OTP) and builds on prior guidance by answering 36 specific questions. Key topics include proof-of-concept data requirements for clinical trials, surrogate endpoints for accelerated approval, and biomarker evaluation. It also expands on a 2020 CMC guidance advising on data needed for Phase 1 studies and BLA submissions. For safety monitoring, the FDA recommends observing trial participants for delayed adverse events for up to 15 years. Here are the key points from as many of the questions as we can fit in a post. Head to the link in the comments for our full breakdown. Q1: Commercial INDs must be submitted in eCTD format through FDA's Electronic Submission Gateway; noncommercial (research) INDs have optional eCTD format. ——— Q2: Original IND submissions require Form FDA 1571, a cover letter, detailed CMC information, pharmacology/toxicology data, and clinical protocols. All documents must be in English. ——— Q3: Form FDA 1571 is required for IND submissions, must be signed by the sponsor/authorized representative, and includes an overview of submission contents. ——— Q4: The 30-day IND review process involves administrative review, discipline reviews (CMC, pharmacology/toxicology, clinical), and determination if it is safe to proceed or if a clinical hold is needed. ——— Q5: Tracking numbers are pre-assigned by CBER for eCTD submissions and must be requested via email to [email protected]. ——— Q6: INTERACT meetings are for early development discussion before toxicology studies; pre-IND meetings are for feedback before IND submission. ——— Q7: INTERACT and pre-IND meetings have specific requirements for briefing packages and timing of submissions. ——— Q8: Type D meetings focus on narrow issues (max 2 topics) requiring input from no more than 3 disciplines. ——— Q9: Pre-BLA meetings are strongly recommended to ensure complete application and avoid review delays. ——— Q10: Manufacturing changes affecting product quality must be submitted as amendments before implementation; new protocols can be implemented after submission to FDA and IRB approval. ——— Q11: Rolling review for qualifying BLAs allows FDA to review portions before complete submission; the review clock starts when the final module is received. ——— Q12: Autologous products don't require donor eligibility determination; allogeneic products require full donor screening and testing. ——— Q13-Q36: See the link in the comments for more takeaways. Flip through the whole guidance below and contact us for access to specialized CGT RA/QA professionals ? #fda #gct #cellandgenetherapy

Want to know what's been catching our attention lately? ?? PhRMA has proposed amendments to the FDA’s planned survey of compounding facilities, suggesting the inclusion of questions on how these facilities intend to comply with applicable federal laws and policies. Their proposal includes eight specific questions, with one notably focusing on the procedures for "surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA." ? https://lnkd.in/gDRSZZwx ?? An analysis conducted by the U.S. Pharmacopoeia has revealed that pharmaceutical manufacturing, particularly for APIs, is highly concentrated among a few countries globally. The Supply Map from this study highlights that these nations hold a disproportionately high capacity for API production, pointing to potential vulnerabilities in the global supply chain ? https://lnkd.in/geR2tdVB ?? The CDER Office of Compliance has issued a new Untitled Letter to a Chinese drug manufacturer, summarizing quality issues found at the company's facility. Notably, this letter followed an FDA remote inspection that relied on records submitted by the company, marking a significant step in how inspections are conducted and compliance issues are addressed ? https://lnkd.in/g4QjcbSQ ?? The FDA Law Blog has published an interesting review on 513(g) requests, which allow companies to inquire whether a proposed product qualifies as a medical device and, if so, determine its classification. This classification helps understand the appropriate review and application procedures that should be followed. The review, however, notes that the FDA’s responses to these requests often leave the industry underwhelmed, primarily due to lengthy delays in receiving feedback ? https://lnkd.in/g8WpZpAj ?? The FDA's Oncology Center of Excellence (OCE) has recently updated its list of programs and projects, removing "Project Beyond Breakthrough."?This initiative aimed to identify and implement best practices to expedite the development of drugs and biological products designated as breakthrough therapies. The OCE continues to lead various other projects to advance oncology product development and regulation ? https://lnkd.in/gggSfbvD ——— Want news roll-ups like this in your inbox? Subscribe to our Insider Newsletter and get handy industry intel and analysis from industry experts and former FDA professionals ? https://lnkd.in/ggUan3Rh

Need some clear thinking around integrating AI into a life science supply chain? We recently sat down with Jennifer Chew, Vice President of Solutions and Consulting at Bristlecone to understand the practical ways companies can start implementing AI today — from automating basic RFP reviews to transforming multi-day planning sessions into hours. Jen brings deep expertise in helping Global 2000 companies navigate supply chain challenges, particularly in life sciences, and shares insights on building AI capabilities while maintaining regulatory compliance. Jen sheds light on things like: - Starting with simple use cases and scaling strategically - Building the right data foundation for AI implementations - How AI can enhance core processes like S&OP - Maintaining regulatory compliance while innovating - Preparing for AI's future in the life sciences supply chain Watch the first few minutes below or catch the full conversation on your preferred platform: ? YouTube: https://lnkd.in/g5BV2QkZ ? Apple Podcasts: https://lnkd.in/dtUwnXr ? Spotify: https://lnkd.in/gu9zi5SJ ? Substack: https://lnkd.in/gQ5zJ3zu ? Web + Others: https://lnkd.in/gHcBSVYp #ai #lifescience #lifesciencesupplychain

Flip through our new case study to see how?we helped a virtual pharmaceutical startup transform its Quality operations after acquiring rights to a life-saving drug. What began as basic SOP development evolved into an 18-month partnership that delivered: - A right-sized QMS for virtual operations - Foreign CMO oversight - Distribution center qualification - Complaint handling systems - An FDA reporting framework - Supplier qualification for expansion ——— A few key wins: ? Reduced distribution audits from 15 to 5 ? Maintained critical drug supply during scale-up ? Built a foundation for internal Quality team success See how flexible consulting partnerships can help virtual pharma companies build FDA-compliant systems while staying operational ?

The FDA Group's Nicholas Capman recently joined Eric Dillman of Eric Dillman Designs and host of the Pro Series Podcast to share a few insights from The Passionate Workforce (https://lnkd.in/gymgvqnd) on creating a driven workforce and the critical strategies for success at every stage of the product lifecycle. Big thanks to Eric for the great discussion! Watch or listen on your preferred platform: ? YouTube: https://lnkd.in/gqemhxQ4 ? Apple Podcasts: https://lnkd.in/grGQjJdg ? Spotify: https://lnkd.in/gShBuewZ