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CDER is seeking comments on the development of its Quality Management Maturity (QMM) program, establishing a public docket to collect input from stakeholders who manufacture human drugs, including biologics. Read More
Our coverage spans relief from third party funded mass tort litigation sought by the medical device industry to Apple prevailing in Masimo patent appeal and two class I device recalls. Read More
HHS has petitioned a federal court to toss out a lawsuit from Merck challenging the constitutionality of the Inflation Reduction Act (IRA)’s ability to empower Medicare to negotiate select prices of costly drugs. Read More
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 say in their reply to the accusation that the companies engaged in acts of terrorism. Read More
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