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 ...

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 The final guidance leaves largely untouched a 2017 draft guidance ...

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 ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

On Thursday, the Food and Drug Administration (FDA) publicly called out companies charged with blocking the development of generic drugs. According to generic manufacturers, brand name manufacturers ...

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those ...