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

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 ...

The previous piece in this series identified tactics used by brand-name pharmaceutical manufacturers to extend their market ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

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 ...

Drug industry representatives and patient and consumer advocates testifying to FDA officials Thursday agreed on one aspect of ...

Generic drugs are cheaper copies of brand drugs, offering significant savings to patients. Once a brand-name drug's patent expires, competitors can apply to make generic versions. Generic ...

Health and Human Services Secretary Robert F. Kennedy Jr. unveiled a new plan on Wednesday that he said will drastically reduce drug prices in the U.S. He said the U.S. Food and Drug Administration is ...

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 ...

Generic drug manufacturers are facing increasing pressure from drug distributors, pharmacy benefit managers, and Indian competitors, leading to downward trends in generic drug prices. Which firms are ...