Bhupesh Pratap’s Post

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Driving innovation and excellence in 505 (B2) products and PBPK modelling . Ex- Dr. Reddys's, Ex-Intas, Ex-Glenmark Ex-Perrigo

➡️ Today, FDA published a new batch of product-specific guidances (PSGs). Today’s batch of PSGs includes: ✅ 26 new PSGs, including 10 for new chemical entities (NCEs), and 6 revised PSGs ✅ 25 PSGs for products with no approved ANDAs (including 11 complex products) ✅13 PSGs for complex products (8 new and 5 revised PSGs) PSGs for products used for treatment of paroxysmal nocturnal hemoglobinuria, Parkinson’s disease, Friedreich's ataxia, mantle cell lymphoma, and other conditions. These PSGs reference products used for treatment of opioid overdose, cystic fibrosis, and other conditions https://lnkd.in/geYxh5mc #FDA #GMP #ANDA #PKSTUDIES #Guidance

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