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 ...

Additionally, some commenters said there should be a dedicated program for complex generic development as part of GDUFA IV. The recommendations were made by members of the generic drug industry as it ...

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 ...

The US Food and Drug Administration (FDA) has finalized guidance for industry on the pathway for discussions about complex products. The final guidance leaves largely untouched a 2017 draft guidance ...

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 ...