Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee...more
As promised, the Food and Drug Administration (FDA) updated the Purple Book: Database of FDA-licensed Biological Products, providing greater transparency and more user-friendly search functionality for the biological product...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
12/17/2019
/ Biosimilars ,
Biosimilars Action Plan (BAP) ,
Biotechnology ,
BPCIA ,
Clinical Trials ,
FDA Commissioner ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigational New Drug Application (IND) ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regenerative Medicine ,
Regulatory Agenda ,
Regulatory Standards ,
Stem cells
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability...more