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 ...

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 ...

Pharmaceutical industry officials speaking at a Wednesday workshop on complex generics suggested that the US Food and Drug Administration (FDA) create alternative pathways for assessing bioequivalence ...

Generic drug repurposing is an underused but promising tool for finding new, affordable therapies. Creating a pull incentive can spur developers to finally explore the untapped potential in these ...

Opportunities lie in mastering FDA procedures for INDs, NDAs, and ANDAs in the largest pharma market, enhancing compliance, understanding regulatory strategies, and improving FDA communications.

Let’s start this story with a sing-along to the tune of “My Favorite Things.” Foundayo, Mounjaro, Zepbound and Ozempic. Skyrizi, Wegovy, Rinvoq and Dupixent. Tremfya, Jardiance, Nurtec ODT. These are ...

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 ...

India got it earlier this year, and Canada approved it last month. But when is the United States going to get a generic ...

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 ...

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 ...