🔎 Check out this Regulatory Focus article from RAPS on the Remote Regulatory Assessments (RRAs) talks from Day 2 of FDA's Generic Drugs Forum (GDF) 2024. 💡 Learn more by visiting: https://lnkd.in/eyCjeDjx
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 41,181 followers
FDA’s information and training source for the regulated pharmaceutical industry
About us
FDA’s information source for small pharmaceutical business and industry; CDER SBIA educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
- Website
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http://www.fda.gov/cdersbia
External link for CDER Small Business and Industry Assistance (SBIA)
- Industry
- Pharmaceutical Manufacturing
- Company size
- 5,001-10,000 employees
- Headquarters
- Silver Spring, MD
Updates
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Nanomaterials are a challenging scientific area but one that presents with many opportunities. Listen to Dr. Andrei Ponta, a review chemist in CDER’s Office of Pharmaceutical Quality, discuss considerations for drug products that contain nanomaterials at https://lnkd.in/e3eiGJwZ and read more at https://lnkd.in/eVcWBTjQ
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Learn more about the new CDER Center for Clinical Trial Innovation (C3TI). C3TI is a central hub that supports innovative approaches to clinical trials to improve the efficiency of drug development. C3TI aims to promote existing CDER programs and spur future innovation activities through enhanced communication and collaboration, with the ultimate goal of accelerating the developing of safe and effective new drugs.
CDER Center for Clinical Trial Innovation (C3TI)
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🔔 In-person attendance still available! SBIA | Join us at the Regulatory Education for Industry (REdI) Annual Conference Join keynote speaker Commissioner of Food and Drugs Robert M. Califf at the Regulatory Education for Industry (REdI) Annual Conference 2024. Learn about the state of medical product innovation from FDA leadership in drugs, biologics, and medical devices. This special, no-cost, two-day event will offer valuable insights into current and upcoming FDA actives in these vital areas. The "drugs track" will address topics such as enhancing clinical trial designs & innovative strategies through the new CDER Center on Clinical Trial Innovation (C3TI), provide updates & cutting-edge insight on novel artificial intelligence (AI) in drug development, and more. There’s still time to register! https://lnkd.in/e6yYMTUZ
Regulatory Education for Industry (REdI) Annual Conference 2024: Innov
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Are you a researcher, sponsor, or industry professional involved in bioanalysis? Do you submit INDs, NDAs, BLAs, or ANDAs that include bioanalytical study data? Are you are involved in GLP-regulated nonclinical laboratory studies and Animal Rule studies data? Then don’t miss this special, informative event. FDA experts will discuss: Expectations during BA/BE Inspections, good Laboratory Practice (GLP) /Animal Rule (AR) Compliance Programs and inspections, and more! https://lnkd.in/dNguqmBz Tahseen Mirza Seongeun Cho Arindam Dasgupta Chuck Bonapace Nora Lim
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Do you work on over-the-counter (OTC) monograph drug products and/or non-prescription drugs? If so, attend this no-cost webinar for an overview of the Over-the-Counter Drug User Fee Program (OMUFA). Learn about fees, registration, timelines and more from FDA experts. 🔔 Don’t miss it! https://lnkd.in/dafKebhU
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🔔 NEXT WEEK: If you are a pharmaceutical regulatory or data scientist, clinical reviewer, medical professional, statistician, statistical programmer, or medical writer working on clinical trial safety analyses for new drug marketing applications, don’t miss Statistical Considerations for Premarketing Risk Assessment on May 16! Learn from FDA experts and earn 1.5 CME /CPE /CNE! Register today: https://lnkd.in/eQQ733Gb
Statistical Considerations for Premarketing Risk Assessment
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🎓 Test your knowledge in anticipation our upcoming Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development on May 29-30, 2024, by responding to the question below. The answer will be posted once the poll closes. 🔔 Register to attend: https://lnkd.in/e6yYMTUZ
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🔔 Don’t wait to register: Room block closes today! Learn about the state of medical product innovation and the FDA’s current and planned activities from top FDA leadership the Regulatory Education for Industry (REdI) Annual Conference 2024. Special guest Commissioner of Food and Drugs Robert M. Califf will give the keynote address! Get key insights on developments in drugs, biologics, and medical devices at this no-cost event. https://lnkd.in/e6yYMTUZ
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development
fda.gov
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Is a medical device applicant required to use FDA consensus standards in their premarket submission? A. Yes B. Only if referenced into a regulation C. No 💡 Do you know the answer? Quiz yourself in anticipation of our upcoming Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development on May 29-30, 2024, by responding to the question above. The answer will be posted once the poll closes. 📅 Register to attend here: https://lnkd.in/e6yYMTUZ
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