Ireland’s NSAI Becomes 11th Notified Body Under EU MDR
NSAI said it will begin accepting applications for conformity assessment activities from April 1, 2020. Source: Devices & Diagnostics Letter
Fist Assist Devices Earns CE Mark for Vein Compression Device
The device is used in AV fistula placement and phlebotomy procedures and has not yet received FDA clearance. Source: Devices & Diagnostics Letter
CDC Issues New Coronavirus Test Reagents
The CDC also reported increased demand for respirators and facemasks. Source: Devices & Diagnostics Letter
First Genetic Test for Fragile X Syndrome Cleared
The syndrome can cause learning disabilities, delays in development, intellectual disabilities, autism and social/behavioral issues. Source: Devices & Diagnostics Letter
CBER Issues 2020 Guidance Agenda
The center has already issued three guidances for sponsors of gene therapy products for specific rare diseases. Source: Devices & Diagnostics Letter
Eisai Withdraws Belviq Over Cancer Concerns
The agency announced a possible risk of cancer associated with the drug based on clinical trial data. Source: Devices & Diagnostics Letter
FDA Approves Three Drugs Through Rx-to-OTC Switch Process
The agency also approved two Alcon products for relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander. Source: Devices & Diagnostics Letter
Soligenix Nabs Fast Track Status for RiVax
The company received funding for RiVax from the FDA and the National Institute of Allergy and Infectious Diseases (NIAID). Source: Devices & Diagnostics Letter
FDA Grants Priority Review for Liso-Cel in B-cell Lymphoma
Liso-cel was previously granted breakthrough therapy and regenerative medicine advanced therapy designations. Source: Devices & Diagnostics Letter
Three More States Pursue Drug Price Controls
Washington, Wisconsin and Minnesota advanced new efforts last week aimed at lowering prescription drug prices, joining more than 128 drug pricing bills making their way through legislatures across the country.…