Archive for September 2023

Citing a continued dramatic growth in the use of laboratory-developed tests (LDT) over the past two decades, the FDA Friday announced a proposed rule that would bring the tests under the agency’s purview, trying a new route to put to rest the decades-long debate over who should provide oversight. Source: Drug Industry Daily

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 clear end in sight. Source: Drug Industry Daily

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 material facts entitle BI to judgment as a matter of law. Source: Drug Industry Daily

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 in labeling antimicrobial susceptibility test system devices, an electronic submission template for De Novo medical device requests, and developing drugs and biologics for graft-versus-host diseases.…

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 Medicare Part D high cost drugs, the company was also filing a motion for summary judgment for the courts to declare the IRA unconstitutional. Source:…

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 safety history. Source: Drug Industry Daily

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 antimicrobial susceptibility test system devices, issuing four new guidances. Source: Drug Industry Daily

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: Drug Industry Daily

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 lack of consistent data and ill-defined biomarkers. Source: Drug Industry Daily