More FDA Guidance Needed to Untangle Combination Product Regulations
The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s…
Cardiosave IABP Sees Third Class I Recall in Less Than a Year
Datascope/Maquet/Getinge’s Cardiosave Hybrid and Rescue Intra-aortic Balloon Pump (IABP) is seeing a recall deemed class I — the most serious type of recall as use of the device may cause…
Appeals Court Rules in Favor of Axonics in Ongoing Medtronic Patent Dispute
A federal appeals court handed another win to Axonics in its ongoing battle with Medtronic over claims that Medtronic’s patents for a sacral-nerve stimulation device are invalid. Source: Drug Industry…
Classification Categories, Formal Meetings Under BsUFA III Explained in Draft Guidances
Two draft guidances with the FDA’s recommendations for Biosimilar User Fee Act (BsUFA III) classification categories and preparation for formal meetings with agency staff were issued today. Source: Drug Industry…
Balance Benefits, Risks of Collecting Diverse Patient Data Post-Approval, Guidance Says
Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the…
Novo Nordisk, Regeneron Expand Pipelines With Weight Loss, Hearing Acquisitions
Two large pharmaceuticals announced acquisitions designed to bolster their portfolios in biotechnology with Novo Nordisk — maker of Wegovy — acquiring Inversago Pharma, also working on a weight loss drug;…
FDA Drug and Device Approvals — July to August 2023
The latest FDA drug approvals include traditional approval of pralsetinib for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, a monoclonal antibody for infants and children at severe risk…
Multiple Warning Letters Advance FDA’s Fight Against DEG-EG Contamination
The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially…
Texas Settles Vyvanse Medicaid Fraud Allegations With Takeda, Baxter for $42 Million
Texas has settled with Takeda Pharmaceuticals and Baxter International for $42 million over allegations the companies provided kickbacks to Medicaid providers to recommend prescription medications including the attention deficit hyperactivity…
Device Cybersecurity Patches are Design Changes
Cybersecurity patches — both proactive to address potential threats and reactive to respond to threats that have already occurred — can be expected to be part of any connected device’s…
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