A government shut down as of midnight on Saturday — the end of the fiscal year — appears likely as partisan disagreements about federal discretionary spending rage on with no…
Boehringer Ingelheim (BI) has filed a motion for summary judgment in its case against HHS objecting to the Inflation Reduction Act’s (IRA) drug price negotiation program, claiming that the undisputed…
Recommendations on labeling of injectable prescription drug product information submitted in an NDA or certain BLAs is the subject of an FDA guidance on dose banding. Source: Drug Industry Daily
Over the past week, the FDA issued final guidance on quality system considerations and content of premarket submissions for cybersecurity in medical devices. Draft guidances were issued on updating breakpoints…
Around the same time AstraZeneca was signing its price negotiation agreement with CMS for its diabetes drug Farxiga, which is included in the Inflation Reduction Act’s (IRA) first list of…
Royal Philips has denied reports that it withheld evidence of sleep and respiratory ventilator product malfunctions for more than a decade, arguing that recent media articles mischaracterize the Amsterdam-based devicemaker’s…
The FDA has provided further direction on developing therapies for graft-versus-host diseases (GvHD), technical considerations for devices with physiologic closed-loop controls, electronic De Novo requests, and breakpoints in labeling for…
Our coverage includes EMA’s revocation of conditional marketing authorization for Blenrep, FDA approvals for Pfizer’s Bosulif and Viatris/Ocuphire Pharma Ryzumvi, and the FY 2024 priority review voucher fee rate. Source:…
Despite strong testimony and comments from patients and clinicians, the FDA advisory committee reviewing NurOwn, an investigational treatment for amyotrophic lateral sclerosis (ALS), voted against recommending the drug, citing a…
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, the 18th Annual…