February and March inspections deferred unless any are deemed mission critical. China director remains behind as staff evacuate.
The US Food and Drug Administration says it stopped conducting inspections in China after the State Department on 30 January issued a warning against traveling there due to the novel coronavirus now called SARS-CoV-2.
The travel warning came a day after the State Department authorized the departure of non-emergency government personnel and their families...
Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.
The Pediatric Advisory Committee will review postmarketing safety for three vaccines and the oncologic drugs panel will consider the return of GSK’s belantamab mafodotin. An FDA notice about a 30 July meeting on Capricor’s deramiocel for Duchenne muscular dystrophy was withdrawn.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
