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…
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…
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…
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. Source:…
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.…
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…
Jazz Pharmaceuticals has become the 25th drugmaker to reduce its participation in the controversial 340B Discount Drug Program. Source: Drug Industry Daily
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…
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…
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…