The Competitive Generic Therapy designation looks to encourage the development of alternatives for drugs with inadequate generic competition. The Food and Drug Administration on Wednesday approved a ...

Rader reasoned that the expedited generic drug approval process created by the Act required drug testing by the generic manufacturer prior to patent expiration and that § 271 (e) (1) thus covers only ...

It’s very early in Scott Gottlieb’s tenure at the FDA, but I like what he has to say about generic drug approvals. Several times here, I’ve gone on about how a lot of the terrible pricing situations ...

Improperly issued drug patents can and do delay the entry of generic drugs. Indeed, a key strategy of brand-name pharmaceutical manufacturers is to obtain patents not just for active ingredients, but ...

Defining the steps involved in a successful technology transfer process would benefit biopharma, say the researchers behind a “generic” blueprint intended to help drug makers move more easily from ...