The drug manufacturing industry in the United States has been subject to intense scrutiny over its role in high drug prices.

FDA Outlines New Communication Process for Generic Drug Companies The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, ...

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 ...

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary ...

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 US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

Indian pharma steps up innovation push, expands focus beyond generics to new therapeutic discoveries: Nandita Vijayasimha, Bengaluru Saturday, April 25, 2026, 08:00 Hrs [IST] Indi ...

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 ...

As drug prices continue to rise and the affordability of medicines for patients remains out of reach, finding new and creative solutions that address affordability, while also rewarding innovation, is ...