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 ...

The United States leads the world in pharmaceutical innovation, with research and development expenditures of over $103 ...

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 ...

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 ...

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.

Ed Silverman formerly piloted The Wall Street Journal's Pharmalot blog tracking the pharmaceutical industry. His coverage included research and development, marketing, pricing, regulation, deals, ...

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 ...