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 ...

Millions of Americans report that they are unable to fill their prescriptions or are not taking their medications as prescribed because they cannot afford them, generating bipartisan interest in ...

The next iteration of the Generic Drug User Fee Amendments program should focus on enhancing communications between the US Food and Drug Administration (FDA) and generic drug applicants, industry ...

The US Food and Drug Administration (FDA) has published a manual of policies and procedures (MAPP) outlining how the Office of Generic Drugs (OGD) will classify which new drugs and drug-device ...

Photo courtesy of starline on Freepik. Opinions expressed by Digital Journal contributors are their own. Santosh Kesarpu has established expertise in complex generic formulation, applying rigorous ...

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 ...

Attempts to curtail the cost of pharmaceuticals by both political parties have drastically increased as millions of Americans are unable to fill their prescriptions due to cost, leading to lapses in ...