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
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 41,401 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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📝 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FDA issued the “Platform Technology Designation Program for Drug Development” draft guidance.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 Read Draft Guidance: https://lnkd.in/eakEZzMg Read Federal Register Notice: https://lnkd.in/efua57cs
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Don’t miss out! The 2024 Regulatory Education for Industry (REdI) Conference kicks-off tomorrow (May 29-30). The conference will be recorded on YouTube Live, and all registered attendees will be able to view at the end of each day. https://lnkd.in/gV5PvVmy #MedicalDevice #FDA
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FDA published the FY 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Report summarizing the scientific progress and research outcomes that support the development and assessment of generic drugs: https://lnkd.in/efVXP2aa GDUFA research provided the scientific foundation for the approval of complex generic drugs, such as medicines used to treat patients with alcohol use disorder and opioid dependence. GDUFA research helps FDA establish new approaches for manufacturers to develop generic drugs that were previously too challenging to develop, which helps make more generic medicines available. Read the report for more information.
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#ICYMI: View the recordings from the Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes webinar to learn how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. View the recordings here ➡ https://lnkd.in/eBJNg82z
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When will the facilities first registered with FDA on or after the declaration of the COVID-19 PHE for the sole purpose of producing hand sanitizer products during the COVID-19 PHE need to cease production of hand sanitizer products and deregister from FDA's eDRLS to avoid FY 2025 facility fees? A. Cease production of hand sanitizer products and update registration and listing accordingly, before 12:00 a.m. EST on December 31, 2024 B. No need to do anything C. 45 days after the publication of the federal register notice D. None of the above 💡 Test your knowledge in anticipation of our upcoming OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration by responding to the question below. The answer will be posted once the poll closes. Register to attend the webinar ➡ https://lnkd.in/dafKebhU
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CDER Small Business and Industry Assistance (SBIA) reposted this
This Clinical Trials Day we celebrate the breakthroughs in science and technology that bring new opportunities to advance innovation in medicine, which help provide novel treatment options for patients and make clinical trials more accessible. Learn more in this FDA Voices article ➡ https://lnkd.in/euVebyjV The recently established Center for Clinical Trial Innovation (C3TI) will enable and amplify innovative approaches to clinical trials that are designed to improve the efficiency of drug development. Learn more about C3TI ➡ https://lnkd.in/gwmKUxsj