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BLOGS
Drug Shortages and Human Drug Compounding - a quick review.
Effective 02/21/25, semaglutide ( Ozempic and Wegovy) drug shortage is finally resolved since its declaration of shortage since August...
Binh Nguyen
Feb 232 min read
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Advanced Manufacturing and 211.110 "Sampling and testing of in-process materials and drug products"
FDA just posted a Draft Guidance "Considerations for Complying With 21 CFR 211.110" ( https://www.fda.gov/media/184825/download ) in Jan...
Binh Nguyen
Jan 152 min read
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Combination Products and Landscape
Did you know that Office of Combination Products (OCP) at FDA was established in 2002 as required by Sec. 204 of the Medical Device User...
Binh Nguyen
Dec 14, 20243 min read
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