The U.S. FDA’s position on predetermined change control protocols (PCCPs) is still in draft form, even though at least one company has won a marketing authorization with a PCCP attached to the underlying artificial intelligence (AI) algorithm. While the agency is still on the fence about a PCCP that incorporates a potential change in the indication for use, regulatory attorney Brigid DeCoursey Bondoc told BioWorld that industry should not reflexively avoid proposing a PCCP with a such change so long as the proposal includes answers to the questions the FDA is sure to ask.
Lush vegetation is great for a gardener, but alarming for a cardiologist. For them, the news that Angiodynamics Inc. received U.S. FDA breakthrough device designation for its Angiovac system to remove vegetation from the right heart is surely cheering. Right heart vegetations--masses of fibrin, platelets and infectious pathogens--are indications of serious infective endocarditis.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Arcellx, Avidity, Biocorrx, Biostax, Immpact, Oncusp, Pfizer, Thryv, Tiziana, Venatorx, Wugen.
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
Venatorx Pharmaceuticals Inc. on Aug. 15 said the U.S. FDA accepted its NDA for an intravenous antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infection (cUTI), including acute pyelonephritis.
Often when the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) determines that the marketing of a drug crosses the line of misbranding, it hands the sponsor an untitled letter schooling it on how the promotional materials run afoul on safety or efficacy claims.
Dicot AB has received clearance from the Swedish Medical Products Agency to begin a first-in-human trial with LIB-01, a potency agent to treat erectile dysfunction and premature ejaculation.
A recent bipartisan request for funding of a study on replacing U.S. drug patents with cash prizes is just one more symptom of a larger global malady that makes patents the scapegoat for bigger problems that have nothing to do with intellectual property (IP), David Kappos, board co-chair of the Council for Innovation Promotion (C4IP), told BioWorld.
Less than a week after approving Johnson & Johnson’s bispecific antibody, Talvey (talquetamab-tgvs), for relapsed or refractory multiple myeloma (r/r MM) under accelerated review, the U.S. FDA has followed suit with Pfizer Inc.’s equivalent, Elrexfio (elranatamab-bcmm). The accelerated clearance of Elrexfio – a B-cell maturation antigen (BCMA) bispecific antibody that targets BCMA on myeloma cells and the CD3 receptor on T cells – covers it for adult patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
The Biden administration recently announced an extension of the comment period for a request for information on harmonization of cybersecurity regulation, a proposal that could conflict with FDA regulation of medical device cybersecurity.
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