Archive for February 2020

NSAI said it will begin accepting applications for conformity assessment activities from April 1, 2020. Source: Devices & Diagnostics Letter

The device is used in AV fistula placement and phlebotomy procedures and has not yet received FDA clearance. Source: Devices & Diagnostics Letter

The CDC also reported increased demand for respirators and facemasks. Source: Devices & Diagnostics Letter

The syndrome can cause learning disabilities, delays in development, intellectual disabilities, autism and social/behavioral issues. Source: Devices & Diagnostics Letter

The center has already issued three guidances for sponsors of gene therapy products for specific rare diseases. Source: Devices & Diagnostics Letter

The agency announced a possible risk of cancer associated with the drug based on clinical trial data. Source: Devices & Diagnostics Letter

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

The company received funding for RiVax from the FDA and the National Institute of Allergy and Infectious Diseases (NIAID). Source: Devices & Diagnostics Letter

Liso-cel was previously granted breakthrough therapy and regenerative medicine advanced therapy designations. Source: Devices & Diagnostics Letter

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. Source: Devices & Diagnostics Letter