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

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: â–¶ YouTube: https://lnkd.in/gqemhxQ4 â–¶ Apple Podcasts: https://lnkd.in/grGQjJdg â–¶ Spotify: https://lnkd.in/gShBuewZ

A review of three recent FDA warning letters to medical device manufacturers reveals a few similarities in quality system deficiencies, highlighting systemic issues across different device categories. We've pulled out the common problems the FDA is finding and citing. Read the full warning letters: 1: https://lnkd.in/gHqc2p3T 2: https://lnkd.in/g64qE_KA 3: https://lnkd.in/g7tQz65c 🚩 Design Control System Failures Arguably the most significant shared deficiency centers on fundamental design control failures. In one case, a manufacturer of sterile convenience kits failed to validate 25 different FDA product codes, including critical surgical kits where a medium-risk cautery component and smoke evacuation device had never been verified for ethylene oxide sterilization compatibility. Two X-ray system manufacturers demonstrated similar oversights — one shipped a Class II portable system without any design validation or risk analysis documentation since 2023, while another failed to validate its imaging panel integration and control software, critical components that directly affect diagnostic image quality and system performance. 🚩 Documentation and Records Documentation failures were pervasive and specific. One manufacturer couldn't provide DMFs for any of their 25 product codes, leaving no trail of design decisions or component verification. Another lacked basic assembly and manufacturing documentation, with no records showing whether technicians completed critical production steps or followed required procedures. The third inappropriately documented significant design changes as temporary manufacturing deviations, bypassing crucial verification requirements for changes affecting product fit, form, and function. 🚩 CAPA System Inadequacies CAPA systems showed critical weaknesses. In one case, 19 CAPAs implemented between 2022 and 2024 had no verification of effectiveness and no documented evidence of implementation. Another manufacturer's CAPA system failed to employ any statistical methodology to detect recurring quality problems, with no trending of device failures or analysis of quality data patterns. Field issues, including software failures affecting device operation and humidity-related generator malfunctions, weren't properly investigated or corrected. —— 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.

The US Government Accountability Office (GAO) is out with a new report outlining concerns regarding the staffing of the FDA’s drug inspection program — problems the office says are limiting the FDA's capacity to conduct inspections. The report highlights that the agency is conducting significantly fewer inspections than its peak in 2016. Despite a partial recovery from the backlog of pharmaceutical manufacturing site inspections caused by the pandemic, the GAO reported that in 2023, the FDA conducted 36% fewer inspections than it did in 2019. Also, the number of vacancies for FDA drug investigators increased from 25 (out of approximately 250 total inspectors) in November 2021 to 73 vacancies in 2023. The FDA has been focused on addressing investigator vacancies that arose during the pandemic. However, the GAO reports that since then, the loss of experienced investigators due to factors like extensive travel, low pay, and heavy workloads has outpaced hiring efforts, leading to a significant number of relatively inexperienced inspectors. A few other key points from the report: - The FDA has increased its use of mutual recognition agreements to rely on inspection data from trusted foreign regulators as a supplement. - New pilot programs in high-production countries aim to improve foreign inspection transparency and effectiveness, but they face logistical and resource challenges. - GAO recommends that the FDA develop more effective action plans addressing travel, workload, and pay issues to retain skilled investigators and stabilize inspection capacity. ——— Read the full GAO report below and check the link in the comments for our full breakdown ⤵ #fda #gao #inspections #regulatorycompliance

The FDA Group's Nicholas Capman recently joined host Luis Hernandez, MBA on The Wayfinder Show to chat about the importance of setting realistic goals, employee engagement, and fostering a passionate workforce. Nick shares a few insights from his book, including 15 key pillars for employee engagement, the benefits of profit-sharing versus merit-based compensation, and the significance of habits in achieving long-term goals. Thanks a ton to Luis for the conversation! Listen to the discussion on YouTube or your preferred podcast platform: â–¶ YouTube: https://lnkd.in/gYSej-NH â–¶ Spotify: https://lnkd.in/dGMFExqR â–¶ Apple Podcasts: https://lnkd.in/gqHswg4d â–¶ Web + others: https://lnkd.in/gzV8NHAY

Want to know what's been catching our attention lately? 📍 The FDA has released a collection of scientific posters ahead of its upcoming Scientific Computing and Digital Transformation Symposium. These materials offer valuable insights into the agency's internal use of generative AI, providing a comprehensive overview of its applications. The poster gallery is an excellent resource for those interested in exploring this topic further » https://lnkd.in/gwd27Sva 📍 Slides are now available from the FDA’s recent IVD town hall. Brittany Schuck, Deputy Office Director of the FDA's IVD division (OHT7), provided an overview of the Total Product Life Cycle approach for IVDs. This approach encompasses pre- and post-market activities and requirements, aligning with the CDRH standard practice for device regulations. The session also introduced OHT7's leadership and its various divisions, each responsible for various IVDs and technologies. The next webinar is scheduled for December 3 and will focus on registration and listing for both IVDs and Laboratory Developed Tests » https://lnkd.in/gub6z9CX 📍 The FDA is revising hundreds of Product-Specific Guidances to align with the ICH’s M13A guideline on bioequivalence for immediate-release solid oral dosage forms. This update focuses on recommendations regarding fed and fasting studies, ensuring consistency with the new M13A standards. The FDA has announced plans to issue new and revised PSGs for both complex and non-complex generic drug products, including those related to the M13A guideline » https://lnkd.in/gf9RHPQd 📍 Michelle Tarver is officially becoming the Center Director of the CDRH. With over 15 years at CDRH, Tarver previously served as Deputy Center Director and Chief Transformation Officer » https://lnkd.in/gjqKHNT7 📍 Recent research from the FDA focused on nitrosamine drug substance-related impurities (NDSRIs), a class of nitrosamines that are structurally similar to the API in a drug. The study aimed to explore methods for controlling the formation of certain NDSRIs linked to bumetanide, a medication used for treating fluid retention » https://lnkd.in/gdPKjUBN ——— 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/g9PVrzGS

Are promotional reviews part of your life? Need ways to make them more efficient? Check out our recent conversation with Annalise Stromsta Ludtke, M.A., Senior Manager of Marketing and Communications at Vodori and host of Vodori’s Amend & Progress podcast. We went through a few details of the typical review process and chatted about how companies are improving efficiency without sacrificing compliance. Annalise brings a wealth of knowledge on strategies that tackle the most common frustrations, from feedback consolidation to claims management. Watch the first few minutes below and get the whole conversation on YouTube or your preferred podcast platform. ▶ YouTube: https://lnkd.in/g2_rgThj ▶ Apple Podcasts: https://lnkd.in/dtUwnXr ▶ Spotify: https://lnkd.in/d582CSJ ▶ Substack: https://lnkd.in/g_wk97ii ▶ Web + Others: https://lnkd.in/g-wfgZZB Check out Vodori’s Amend & Progress podcast for insights, actionable best practices, and expert perspectives to change how you think about and approach content review: https://lnkd.in/g6Wkqu_6 #promotionalreview