🔔 Earn 10.50 CE hours September 24-25! Join us in person for CDER SBIA’s Advancing Generic Drug Development. Come explore the complex science of generic drug development, interactive poster sessions, Q&As w/ FDA experts, and more ➡️ https://lnkd.in/emXB-9VY
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 44,321 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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📣 Tomorrow! Don't miss our SBIA Sept. 4 Webinar – FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA Is your early-stage small business new to the regulatory landscape? Then don’t miss this SBIA webinar for a chance to learn directly from FDA experts! Get an overview of resources and programs developed across the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) that can help academic life science accelerators and early-stage, oncology-related companies. Q&A sessions will be offered. Register now! ➡ https://lnkd.in/eyKhGgC5 Monique Pond Jeff Summers Paresma (Pinky) Patel Emily W. Loni Warren H. Heather Erdman,MCPM RAC CQPA Karin Knudson Devaveena Dey Dr. Jessica Lee, MD, PhD. Jessica Mavadia-Shukla, PhD Danielle Fau
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
fda.gov
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📝 Test your knowledge in anticipation of our October 9 SBIA ICH M12 Drug-Drug Interaction Studies Final Guidance webinar by responding to the question below. The answer will be posted once the poll closes. 🔔 Make sure to register early! https://lnkd.in/e6ygc4HH Question: What are the most important drug metabolizing enzymes? A. Carboxylesterase (CES) B. Cytochrome P450 (CYP) enzymes C. Monoamine oxidase (MAO) D. UDP glucuronosyl transferases (UGTs)
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🔔 Coming October 16: Global IDMP Implementation - Getting Closer to the Goal Learn directly from FDA experts about how Identification of Medicinal Products (IDMP) offers a global framework for the unique identification and consistent documentation of medicinal products, facilitating effective information exchange among regulators, manufacturers, suppliers, and distributors. Register today: https://lnkd.in/ebhx38Dw
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🔔 Don't miss out! Earn up to 6.5 CEs! Join #CDERSBIA on September 12 to learn more about registration and listing regulatory requirements and compliance framework with a demonstration on how to submit establishment registration and drug listing data using CDER Direct. ☑ Register: https://lnkd.in/e2JG95ck
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🔔 Next week! Join the SBIA Sept. 4 Webinar – FDA | NIH: Regulatory Do’s and Don’ts: Tips from FDA Is your early-stage small business new to the regulatory landscape? Then don’t miss this SBIA webinar for a chance to learn directly from FDA experts! Get an overview of resources and programs developed across the Center for Biologics Evaluation and Research (CBER), the Center for Drug Evaluation and Research (CDER), and the Center for Devices and Radiological Health (CDRH) that can help academic life science accelerators and early-stage, oncology-related companies. Q&A sessions will be offered. Register early! ➡ https://lnkd.in/ehUeuvsz Monique Pond Jeff Summers Paresma (Pinky) Patel Emily W. Loni Warren H. Heather Erdman,MCPM RAC CQPA Karin Knudson Devaveena Dey Dr. Jessica Lee, MD, PhD. Jessica Mavadia-Shukla, PhD Danielle Fau
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA
fda.gov
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📣 Special Rate Room Ends Aug. 30, Book Today! Join us in person for CDER SBIA’s Advancing Generic Drug Development. Come explore the complex science of generic drug development, interactive poster sessions, Q&As w/ FDA experts, and more ➡️ https://lnkd.in/emXB-9VY
Advancing Generic Drug Development: Translating Science to Approval
fda.gov
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🔔Coming October 9: ICH M12 Drug-Drug Interaction Studies Final Guidance If your work relates to drug interactions, drug metabolism, pharmacokinetics, or clinical pharmacology, attend this SBIA webinar! The discussion will include content related to the full scope of the ICH M12 Drug Interaction Studies guidance. Register early! https://lnkd.in/e6ygc4HH
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🔔 Earn 6.5 CE Hours on September 12! Register today for SBIA's Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024 Learn how to submit establishment registration and drug listing (eDRLS) data using CDER Direct. This Small Business and Industry Assistance (SBIA) webinar will feature case studies for an interactive learning experience. https://lnkd.in/e2JG95ck Ugwu-Oju, Obinna Regie Samuel Soo Jin Park Laurie Simonds Lalnunpuii Huber Troy Cu Leyla Rahjou-Esfandiary Yogesh Paruthi, BPharm, PharmD Vikas Arora David Mazyck Julian Chun Tasneem Hussain Jeffrey Trunzo
Advancing Generic Drug Development: Translating Science to Approval
fda.gov
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💡 Is your early-stage company (small business) new to the regulatory landscape at the FDA? Join us September 4th for an overview of FDA resources and programs which can help academic life-science accelerators and early-stage, oncology-related companies, develop new anticancer-therapeutics, devices, and diagnostics. Register here ➡ https://lnkd.in/ehUeuvsz