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This special edition of Quick Notes covers FDA issuance of final guidance for the Breakthrough Device Program, drug postmarketing requirements and commitments and the CDRH voluntary improvement program as well as draft guidances on clinical study design and non-clinical testing of weight loss devices. Read More
Expert witnesses discussed the precarious nature of the U.S. generics supply chain during a House subcommittee hearing Thursday, highlighting how unless reforms are made the country is at risk of decreased access to key medications including chemotherapy drugs. Read More
New FDA drug approvals in August include the first ever oral pill to treat postpartum depression, treatments for two ultra-rare diseases and the first vaccine for use in pregnant women to prevent respiratory syncytial virus (RSV) in infants. Read More
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
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 warning letter to Safecor, a Columbus, Ohio, drug manufacturer and repackaging company. 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
Upcoming events in the coming weeks include eight FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual Inspections vSummit and webinars from FDAnews, a WCG company, on calculating sample sizes for verification and validation activities, medical device counterfeiting and what to expect from the FDA in 2024. Read More