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.
CDER Small Business and Industry Assistance (SBIA)
Pharmaceutical Manufacturing
Silver Spring, MD 41,261 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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#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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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
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Do you need to know more about inspections of Bioavailability/Bioequivalence (BA/BE) and nonclinical Good Laboratory Practice (GLP) studies submitted to FDA? Join us for the OSIS Workshop on June 13, 2024! Register here ➡ https://lnkd.in/dNguqmBz
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A new batch of product specific guidances was released this week for medications that treat diseases and conditions such as opioid overdose, cystic fibrosis, Paroxysmal nocturnal hemoglobinuria, Parkinson’s disease, and others. ✅ Check them out below and access them here: https://lnkd.in/dBpZN4P
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📢 Are you interested in learning directly from the FDA’s regulatory experts in medical product centers: drugs, devices, and biologics? Then join us for the 13th annual Regulatory Education for Industry (REdI) on May 29th-30th, 2024! Register here ➡ https://lnkd.in/e6yYMTUZ
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🔎 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
FDA aims for greater use of remote assessments for low-risk facilities
raps.org
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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