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  • Regulatory NewsRegulatory News

    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (12 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls on Regional Regulators to Work to Resolve Vaccine Shortages The China Food and Drug Administration (CFDA) has called on its regional offices to take steps to resolve the country’s vaccine supply shortage. The request comes at a time when CFDA and the vaccine industry it regulates are adapting to the changes that were proposed in response to the scandal that rece...
  • BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

    An article in The British Medical Journal ( BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times . FDA review staff noted their concerns about the drug's safety and efficacy, according to  The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding...