by inpharmedia | Feb 3, 2023 | Approvals, Blog, Regulatory
The U.S Food and Drug Administration (USFDA) has approved 04 new drugs in the month of January. Out of the 04 approvals, 03 are NDA and 01 is BLA. LEQEMBI ITEMDESCRIPTIONNDA/BLA Number:761269Applicant/Holder:EISAI INCAPI:LecanemabDosage... by inpharmedia | Dec 19, 2021 | Blog, Regulatory
The Hatch-Waxman Act provides certain market exclusivities for new drug applicants based on two factors: Patent Non-patent The patent related exclusivities are part of the discussion and we will learn further in this article. PATENT EXCLUSIVITY & the ORANGE BOOK:... by inpharmedia | Aug 15, 2021 | Blog, Regulatory
Exclusivity: Exclusivity is exclusive marketing rights granted by the Health Authority upon approval of a novel drug molecules and can run concurrently with a patent or not. It prevents the submission or effective approval of generic applications and was designed to...
by inpharmedia | Apr 27, 2021 | Blog, Regulatory
Every new drug must prove to be safe and effective to be approved by any health authorities. The new drug/therapeutic moieties invented are protected by a specific patent that allows the innovator firm or patent holder to enjoy the exclusivity to market the product...
by inpharmedia | Jan 9, 2021 | Blog, Regulatory
The Refuse to Receive (RTR) standards play a critical role in the ANDA (Abbreviated New Drug Application) submission process, acting as the initial gatekeepers for regulatory approval. These standards are designed to ensure that submitted applications meet the...
by inpharmedia | Feb 9, 2020 | Blog, Product Development
What is Inactive Ingredient Database? Inactive Ingredient Database (IIG) Database is a collection and aligned set of inactive ingredients, that are to be present or appeared in FDA approved drug products, allowing industry to access for development of new products....
