This article was originally published in RAJ Devices
UK regulator to set up medical device technology forum
You may also be interested in...
Avadim Health argues National Advertising Division expects substantiation for its homeopathic topical claims at the same level FDA requires for NDAs. NAD also said although FTC’s competent, reliable scientific evidence standard is “flexible” to some degree, pain claims are held to a more rigid standard.
With Roche's oral spinal muscular atrophy therapy Evrysdi off to a strong start after its recent US launch, Novartis is switching its priorities for rival RNA-splicing drug branaplam and putting it into a Phase IIb trial for Huntington's disease.
The FDA has asked the company for more information to support its PoNS therapy for multiple sclerosis patients with gait deficit, including an additional analysis of clinical data and labeling modifications.