Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers....more
3/21/2017
/ 21st Century Cures Act ,
Draft Guidance ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Human Genes ,
Life Sciences ,
Medical Research ,
Public Comment ,
Public Health Service Act ,
Stem cells
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
7/22/2016
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
CAFC ,
Commercial Marketing ,
Exclusivity ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Health Service Act ,
Rulemaking Process
On August 27, 2015, the Food and Drug Administration (FDA) released draft guidance on nonproprietary naming of biological products. The agency’s draft guidance proposes that the core nonproprietary name for originator...more