Stephanie Davenport, MSL

More than a year into GDUFA III the Late-Cycle Amendment provision is still a mystery. Is it working? Has it clarified review timing, or has it made approval dates more unpredictable? Read the analysis below to discover new insights and let me know in the comments if any of these cases match your own experiences or if you have other insights to share!

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BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

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Get ready for Episode 7 of the GxPodcast! 🎙️ This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma. Tune in to hear us discuss quality culture and excellence in life sciences. We look at cell and gene manufacturing, the connection between innovation and purpose, and the importance of data management in our industry. Tune in to the full episode here: 🔗 https://lnkd.in/exW4jkBB #GXPodcast #iPharmGxP

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Curious about how the FDA's guidance on Benefit-Risk Assessment for New Drug and Biologic Products impacts your development program? Read our blog here: https://lnkd.in/enfY73V9

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From GCP and GMP to inspection readiness and remediation issues, our expert QA teams work with companies of all sizes and development stages to support all aspects of clinical and commercial quality across the entire product lifecycle. Samantha Taylor CMgr MCMI, Assistant Vice President of Business Development, is ready to tell you more about how our phase-appropriate, scalable QA support can help you mitigate risk and guarantee compliance. You can book a chat with her here: https://lnkd.in/e6HiZ5ac #HealthcareAdvisors #QualityAssurance #RegulatoryAffairs #RegulatorySupport

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to quote one of the speakers Michael Z. Liao, PhD, MLS “Having a positive personal brand is essential. I’m excited to be part of the panel to discuss how to strengthen your brand with industry leaders Songmao Zheng Sandhya Girish and Mark Lovern. #ascpt #careerconnect #personalbrand #clinicalpharmacology #translationalscience”

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Andrew Fletcher discusses how to get started with a laboratory stewardship committee, and more importantly, the potential cost to the healthcare system and the patient when no committee is available. Watch the recording for CE credit, available at no cost to you, and learn more about our Lab Briefings continuing education offerings, here: https://lnkd.in/grm9-8t4 #lab #pace #labCE #labstewardship #labtesting

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🔥 Coming out of one of the Fireside Chat sessions at the 2024 ASGCT Annual Meeting is more on the need for guidelines, a framework of 'global regulatory convergence' in Cell and Gene Therapy, particularly in the development, manufacturing, and access. Leading the discussion is US #FDA's Marks, CBER Director. 🌎 Marks explained to the audience that varied countries' criteria for CGTs, from preclinical testing to manufacturing, make it difficult for patients in certain parts of the world to obtain treatments, particularly those in the rare disease space. Forward-looking: "Five to 10 years from now, Marks’ vision is that there will be enough global regulatory convergence “such that we can get to where we are currently with vaccines” internationally. “It would reduce regulatory burden.”" #ASGCT #CellAndGeneTherapy #CellTherapy #GeneTherapy #RegulatoryAffairs #Oversight #Innovation #Biotech #Healthcare

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Last week was thrilling as we participated in two key industry events 🚀 —the North Carolina Regulatory Affairs Forum (NCRAF) and the Biomanufacturing and Process Development (BPD) Cell and Gene Therapy Symposium. These events highlight our dedication to leading innovation and regulatory standards in the Life Sciences industry. We are aware of the marked differences between Cell & Gene Therapy (CGT) and Biopharmaceutical BLA submissions and our services are tailored to help both startups and global companies get their products to market faster with guaranteed potency and lifesaving results. #LifeSciences #RegulatoryAffairs #Biomanufacturing #GeneTherapy #NCRAF #BPDSymposium

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Looking for a reliable partner for your pharmaceutical development needs? Seven Star Pharmaceutical Services (Seven Star) has got you covered. Our team specializes in CMC/solid-state chemistry research, crystallization process development, pre-formulation studies and formulation development studies. We also offer comprehensive routine and focused analytical testing services, ensuring accurate and timely results without any compromise on quality. Contact us to learn more about our services. https://lnkd.in/etWhi36 #chemistry #research #pharmaceutical #CMC #drugdevelopment #pharmaceuticaldevelopment #SolidStateChemistry #SaltScreening #CrystallizationScreening #CocrystalScreening #PolymorphScreening #preformulations #formulationdevelopment #MedicinalChemistry #SingleCrystalXrayDiffraction #materialsscience #analyticalresearch #materialsresearch #cdmo #CRO #contractresearch #drugdiscovery #api #crystalform #pharmaceuticaldevelopment 

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The proposed rule, if finalized, will require applicants of all new and approved new drug applications (NDAs) and biologics license applications (BLAs) to create PMI for prescription drug products that are to be used, dispensed, or administered on an outpatient basis.  The proposed rule will also require applicants of new and approved abbreviated new drug applications (ANDAs) that refer to a reference listed drug for which FDA has approved PMI to have PMI that is the same as that of the reference listed drug, except for certain differences in labeling permitted under the law. There will be an FDA template process for ANDAs without a reference listed drug. During the proposed 5-year implementation schedule of the final rule, the current regulations governing Medication Guides will remain in place but will no longer be applicable to a prescription drug product once that prescription drug product has FDA-approved PMI. PMI will replace current Medication Guides and Patient Package Inserts. PMI is not intended to replace the Prescribing Information, Instructions For Use, or patient counseling

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What is culture, and what do we mean by it? Culture means different things to different people, and means different things in different companies. I know what I strive for, though and what I respect. Recently, I had the privilege of witnessing how Dr. Hatti captures and relays culture at Suburban Research Associates an Atlas Clinical Research site. Over many years, Dr Hatti has built and then evolved what his vision of shared stand on how we treat patients, each other, and our partners. I've never seen anything quite like it. It's rare to see someone codify with such clarity, and such love what their work means. Dr. Hatti took the time—really took the time—so that everyone who works there understands how their contributions make a difference. Seeing this has reaffirmed my belief in the power of culture. When done right, it can inspire, motivate, and bring a sense of collective ownership. I love my job... #Leadership #Culture #Inspiration #Teamwork

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities. 

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The FDA's Center for Drug Evaluation and Research has released its latest report on the state of pharmaceutical quality. This report is a comprehensive overview that sheds light on the agency's efforts to ensure the safety, efficacy, and quality of drugs available to patients. In the report you can find topics including: -Trends in manufacturing quality and compliance. -Efforts to modernize manufacturing technologies. -Strategies to address challenges in global drug supply chains. Check out the full report below #PharmaceuticalQuality | #FDA | #DrugSafety | #RegulatoryCompliance #Healthcare | #CDER | #QualityAssurance | #IndustryInsights

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Check out FDA’s Office of Pharmaceutical Quality (OPQ) FY2023 report on the State of Pharmaceutical Quality to learn more about the select quality indicators and trends that provide insight into the quality of the U.S. drug supply. Learn more: https://lnkd.in/gbr4N-2X The report also highlights emerging approaches to surveil, characterize, and advance pharmaceutical quality. FDA uses the Report on the State of Pharmaceutical Quality, in part, to inform regulatory decision making and quality surveillance activities.

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Spotlight On: Doug Edgeton, President & CEO, North Carolina Biotechnology Center (NCBiotech) 4 min read May 2024 —In an interview with #Invest:, Doug Edgeton, president and CEO of North Carolina Biotechnology Center, proudly shared how it has surpassed its key goals set out in its 2025 plan. He highlighted strategies that the company has implemented to diversify its grants and #revenue streams, and how employers seek individuals with skills tailored to working in #biopharma manufacturing. READ MORE: https://lnkd.in/eBBtFDdU

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