Learn directly from FDA experts about prescription drug promotion, including the different categories and types of promotion, as well as regulatory requirements for each. The discussion will cover the clear, conspicuous, and neutral (CCN) final rule, the five standards associated with the rule, and the rule’s compliance date. 🔔 Register today! https://lnkd.in/eyPqVMF4
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 41,527 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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If you work on over-the-counter (OTC) monograph drug products or non-prescription drugs, don’t miss this webinar! FDA experts will offer an overview of the Over-the-Counter Drug User Fee Program (OMUFA) and provide valuable information about fees, registration, timelines, and more. This course has been pre-approved by RAPS, SOCRA, SQA and ACRP, and also offers one contact hour of CME/CPE/CNE. 🔔 Register today! https://lnkd.in/dafKebhU
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Did you know that Artificial Intelligence (AI) is gaining traction in clinical research and changing the clinical trial landscape? Listen in to learn more in this Q&A with FDA podcast with Dr. Khair ElZarrad, Director of CDER’s Office of Medical Policy, and recipient of the 2023 Arthur S. Fleming Award, which honors outstanding federal employees: https://lnkd.in/g7wJvnUi
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CDER Small Business and Industry Assistance (SBIA) reposted this
On May 29, 2024, FDA notified selected participants of their acceptance into the Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program: https://lnkd.in/eFNrXnCV Announced in September 2023, the pilot is an FDA initiative to help further accelerate the development of novel drug and biological products for rare diseases.
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🔐 Unlock innovation with us today! From AI and Machine Learning to NextGen, Advanced Manufacturing, Devices, and Real World Evidence, there's so much to learn. Don't miss out on our free FDA SBIA Regulatory Education and Industry sessions. Register now ➡ https://lnkd.in/e6yYMTUZ
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Drugs, Devices, and Biologics! Register for tomorrow’s no cost FDA SBIA Regulatory Education for Industry sessions: ✔ Artificial Intelligence and Machine Learning ✔ NextGen ✔ Navigating Medical Devices ✔ Blood Regulation ✔ So Much More ➡ https://lnkd.in/e6yYMTUZ
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📝 Can you answer correctly? Test your knowledge in anticipation of our upcoming Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule on June 26, 2024, by responding to the question below. 💡 The answer will be posted once the poll closes. Register to attend the webinar ➡ https://lnkd.in/eyPqVMF4
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📅 What are you doing today and tomorrow? Hopefully attending the FDA’s SBIA Regulatory Education for Industry conference! Check out the agenda below. Still time to register ➡ https://lnkd.in/e6yYMTUZ
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FDA issued the “Platform Technology Designation Program for Drug Development” draft guidance. This program is intended to result in efficiencies in drug or biological product development, manufacturing, and review processes for drugs and biological products incorporating designated platform technologies. Read Draft Guidance: https://lnkd.in/eakEZzMg Read Federal Register Notice: https://lnkd.in/efua57cs