Key Points
- In February, the U.S. Food and Drug Administration issued a "bright-line rule" redefining "biological products" under the Biologics Price Competition and Innovation Act (BPCIA) to include insulin and other...more
3/2/2020
/ Biologics ,
Biosimilars ,
BPCIA ,
Bright-Line Rule ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
PHSA ,
Purple Book
This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more