The US Food and Drug Administration (FDA) approved or tentatively approved 776 Abbreviated New Drug Applications (ANDAs) for generic drugs in 2021, continuing a steady decline in generic approvals in ...

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 ...

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 ...

Sorensen recently reintroduced the bipartisan STOP GAMES Act, legislation aimed at preventing what he describes as "sham" ...

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 ...

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary ...

“[U]nbranded generics make up 90% of total U.S. prescription volume, far greater than the 41% of generics among total prescription volume in other OECD countries.” At approximately the same moment ...

Generic drugs account for more than 90 percent of prescriptions filled in the United States. Recent studies have found concering variability in quality and safety America’s generic drug supply, most ...