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 ...

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 previous piece in this series identified tactics used by brand-name pharmaceutical manufacturers to extend their market exclusivity and deter entry by generic producers. It also examined how the ...

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 ...

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 ...

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

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, ...