40 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FDA Draft Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins FDA Draft Guidance on Drug-Drug Interaction Assessment for Therapeutic Proteins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
FDA Draft Guidance on Licensure of Biosimilars and Interchangeable Biosimilars for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed FDA Draft Guidance on Licensure of Biosimilars and Interchangeable Biosimilars for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed
February 19, 2020
IP Health Blog
FDA Draft Guidance on Biosimilar and Interchangeable Insulin Products FDA Draft Guidance on Biosimilar and Interchangeable Insulin Products
December 27, 2019
IP Health Blog
FDA Guidance on Analytical Assessment of Therapeutic Protein Biosimilars FDA Guidance on Analytical Assessment of Therapeutic Protein Biosimilars
June 5, 2019
IP Health Blog
FDA Final Guidance on Demonstrating Interchangeability With Reference Products FDA Final Guidance on Demonstrating Interchangeability With Reference Products
May 24, 2019
IP Health Blog
FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence FDA Draft Guidance on Submitting Documents Using Real-World Data and Real-World Evidence
May 17, 2019
IP Health Blog
FDA Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351 of the PHS Act FDA Procedures for Handling Requests for Nonproprietary Name Suffix Review for Biological Products Newly Licensed Under Section 351 of the PHS Act
March 20, 2019
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