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…
New bipartisan legislation to increase pharmacy benefit manager (PBM) drug price transparency was introduced Friday by the members of the House Energy and Commerce, Ways and Means and Education and…
Failure modes and effects analysis (FMEA) is a useful tool for medical devicemakers but it is no substitute for a risk assessment, said quality expert Eliot Zaiken in an Aug.…
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily
Royal Philips, Amsterdam-based parent company of Philips Respironics, reports that it’s close to settling multiple lawsuits related to Philips Respironics’ voluntary recall of certain sleep and respiratory care devices. Estimated…