@dansfera: Ever wonder what the FDA means by a 505(b)(1)? 🤯 Think of it as the ultimate blank slate in drug development: a brand-new molecule or API that has *zero* prior FDA approval, even when studied in combination with other existing treatments. This pathway is reserved for substances venturing into truly novel territory. Decoding these regulatory steps reveals so much about where next-generation therapies are coming from! #FDA #DrugDevelopment #PharmaInsights #505b1 #NewMolecules

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Tuesday 17 March 2026 00:06:25 GMT