Jazz Pharmaceuticals has become the 25th drugmaker to reduce its participation in the controversial 340B Discount Drug Program. Source: Drug Industry Daily

A mix up that put a vitamin in a blister pack where a drug to prevent organ transplant rejection belonged is one of several violations the FDA cited in its…

The Anti-Terrorism Act (ATA) requires a much higher level of conscious and culpable participation than just selling Iraqi Health Ministry health supplies, AstraZeneca and five other drug and devices makers…

The Amgen-Horizon Therapeutics merger isn’t quite over the finish line, because — in accordance with consumer protection and anti-competition laws — the FTC is seeking public comment on the consent…

The FDA has issued warning letters to eight companies — including CVS Health and Walgreens Boots Alliance — for manufacturing or marketing illegal, unapproved eye drops to treat pink eye,…

From 2018 to 2022, the FDA took 225 enforcement actions on medical device advertising while the FTC took 67 such actions, says a new report from the Government Accountability Office…

The FDA has announced the second year opportunity for drugmakers to participate in a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to expedite development of products…

Our coverage spans an Adcomm decision on use of phenylephrine, 1Health.io FTC order for failure to protect privacy and security, user fees for OTC monograph order requests and a GDUFA…

The U.S. Department of Justice (DOJ) and Danco Laboratories, manufacturer of Mifeprex (mifepristone), have asked the U.S. Supreme Court to review a lower court’s decision to limit access to the…

Inspection readiness is more than a quick practice session before the FDA investigator arrives; preparation should begin long before an inspection is even announced, say regulatory experts who advise establishing…