Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more
1/29/2021
/ Biden Administration ,
CARES Act ,
Coronavirus/COVID-19 ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Care Providers ,
Orange Book ,
PDUFA ,
Pharmaceutical Industry ,
Public Health Service Act ,
Regulatory Agenda
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