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 The final guidance leaves largely untouched a 2017 draft guidance ...

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 ...

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 ...

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 ...

The course offers significant market opportunities by equipping senior and project managers with essential FDA-related insights, enhancing team interaction, and streamlining drug application processes ...