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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, glaucoma and cataracts and other ophthalmic conditions. Read More
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 (GAO), but officials admitted they have limited resources to actively monitor the entire volume of direct-to-consumer advertising meaning more enforcement action may still be needed. Read More
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 under an investigational new drug application (IND). Read More
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 report available. Read More
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 abortion drug — a move that could push the case to the front of the court’s docket. Read More
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 standard operating procedures that will maintain a constant and thorough state of readiness. Read More
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 the Workforce committees. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
Our coverage spans an Abbott acquisition, FDA draft guidances on endogenous Cushing’s syndrome and peptide drug development, EMA guideline revision on clinical trials for depression treatments and a GAO report on drug rebates in Medicare part D. Read More
The FDA’s latest final guidance features questions and answers on how to apply human factors (HF) engineering principles when developing combination products, clarifying how the uniqueness of these products affect HF engineering considerations for industry and agency staff. Read More