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 ...

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 ...

Given the high stakes involved, the generic exclusivity period’s effects on competition should be scrutinized.

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" ...

Universities and hospitals are repurposing existing drugs through late-stage trials with funded costs up to 90% lower than ...

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 Medication Affordability and Patent Integrity Act would create new regulatory burdens on biotech companies, making it ...