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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 order it recently issued allowing Amgen’s proposed $27.8 billion buyout of the Irish pharmaceutical company to proceed. Read More
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
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
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
This month’s feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG.Read More