USA – Generic manufacturers call for changes to list of major deficiencies
Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA)...
USA – FDA revises guidance on electronic systems and signatures in clinical trials
The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the...
USA – Guidance details updated FDA GDUFA fees, structure and appeals process
The US Food and Drug Administration (FDA) published a final guidance last week that updates the agency’s user fee structure and other aspects of...
USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
Four drugmakers have asked the US Food and Drug Administration (FDA) to amend some of the requirements in its draft guidance on developing migraine prevention...
USA – Pharma industry making some headway in DSCSA implementation
The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA),...
USA – Study: Few FDA-approved targeted cancer drugs meet ESMO benefit benchmarks
Fewer than one-third of molecularly targeted cancer drugs recently approved by the US Food and Drug Administration (FDA) meet established European benchmarks for clinical...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...
USA – Accelerated approval trials: Commenters seek details on single-arm considerations
The US Food and Drug Administration (FDA) aimed to address some of the criticisms of its accelerated approval program with new draft guidance that...
USA – FDA issues final guidance on rare disease drug development
The US Food and Drug Administration (FDA) finalized guidance on drug development programs for rare diseases, eliminating a section on natural history and providing...
