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.

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 ...

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 ...

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 ...

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 ...

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 ...