The report from the HELP Committee continues its track record of comparing US drug prices to those in other countries.

Several senators on both sides of the aisle brought up the many bipartisan bills that have passed the House and Senate committees in recent years.

The collaborative efforts that advance the development of more generic drugs is the work of CDER’s science and research program whose 2023 annual report provides details on the efforts behind the ...

FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...

The FDA has a lot of work to do to regain trust among a wide swath of demographic groups — starting with women — according to a recent survey. Researchers from Harvard Medical School, Brigham and ...

In an analysis that seeks to help frame the discussion at the upcoming Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee, the FDA says that a law enacted in 2017 has increased ...

FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...

FDAnews The trusted source for drug and device insights Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments. For decades, ...

The FDA has imposed import alerts on two additional Chinese manufacturers of plastic syringes, preventing these products from entering the US, and is warning healthcare practitioners as well as ...

Akan Biosciences, the manufacturer of a sterile injectable biologic product, received an FDA Warning Letter for failing to properly test donor tissue samples for communicable diseases and failing to ...