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 ...

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 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 The final guidance leaves largely untouched a 2017 draft guidance ...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 ...

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 ...

Over 80% of U.S. drug prescriptions are for generic medicines. 1 Such medicines are an important part of the medical system, helping to alleviate drug shortages and improve access to affordable ...

If you've had a prescription lately, chances are good it was part of the 91% of U.S. drugs that are considered generic. So, ...

OctoPlus N.V. ("OctoPlus" or the "Company") (Euronext: OCTO) announces today that it has signed a feasibility agreement with a top-5 generics company to develop a generic formulation of an existing ...

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 ...