In an attempt to increase the availability of biosimilars, on July 11, 2024, the Senate passed the Affordable Prescriptions for Patients Act, which was introduced in the House on July 19, 2024. The bill sets a cap of 20...more
As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to ยง 560k of the Federal Food, Drug, and...more
8/14/2024
/ Biologics ,
Coronavirus/COVID-19 ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
Patent Term Extensions ,
Patent Terms ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs