In generic drug development, technical skills alone are not enough. What truly ensures timely success is strong regulatory planning—right from Day 1. Before you even begin pre-formulation work or touch any excipient, you must sit with your Regulatory Affairs team and carefully plan how the product will be registered. This includes understanding FDA requirements, patent…
The 22 sections of an ANDA (Abbreviated New Drug Application) refer to the structured format used for submission to the USFDA, typically following the CTD (Common Technical Document) format. Here’s a simplified list based on how the “Handbook of Pharmaceutical Generic Development” and USFDA expectations outline it: Key Components of the 22 Sections (Non-CTD Format…
Paragraph IV (Para IV) Filing is a certification under the Hatch-Waxman Act that allows a generic drug applicant to challenge a brand-name drug’s patent by claiming either non-infringement or patent invalidity. If successful, the first applicant receives 180 days of market exclusivity, creating a significant commercial advantage. However, the brand-name company can sue within 45…
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