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Latest From Drug Safety
Ophthalmology supervisory medical officer Wiley Chambers played a key role at three different advisory committee meetings in early October. Only one was a review in his division.
From next year drug manufacturers operating in Australia will have to start placing a black triangle symbol on the product information and consumer medicines information documents for certain newly approved prescription products and new indications.
ANDA pathway is not sufficient to review liraglutide generics because of molecule's complexity, Novo contends; Teva appears to be first filer for Victoza.
Australia’s regulator has responded to consultation submissions and is moving forward with plans to issue guidance on biovigilance.
Reeducating prescribers on treating pain will take a long time, FDA Commissioner Scott Gottlieb tells Senate HELP Committee Members.
Treatment guidelines may also appear in opioid labeling, and insurers seem to be taking the agency's advice, but will it be enough to satisfy Congress?
Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.
Lipid increases in sarilumab's clinical program spurred consideration of a cardiovascular outcomes trial postmarketing requirement akin to that conducted for Genentech's Actemra. However, Medical Policy Council's new subcommittee recommended against requiring a study, citing feasibility concerns.
Now-defunct AmerisourceBergen subsidiary inappropriately repackaged oncology support drugs like Neupogen and Procrit in pre-filled syringes, violating the law and prompting safety concerns, Department of Justice announced.
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