6 results
IP Health Blog
FDA Draft Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins FDA Draft Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins
August 21, 2020
IP Health Blog
CAFC Reverses PTAB’s Obviousness Ruling in OSI v. Apotex CAFC Reverses PTAB’s Obviousness Ruling in OSI v. Apotex
December 3, 2019
IP Health Blog
FDA Draft Guidance on Drug Master Files FDA Draft Guidance on Drug Master Files
October 30, 2019
IP Health Blog
FDA Draft Guidance on Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions FDA Draft Guidance on Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions
March 9, 2018
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