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.…

While judging the Medicines and Healthcare products Regulatory Agency’s (MHRA) response to the PIP silicone breast implant scandal basically sound, a new review by the UK Department of Health (DOH)…

A class action lawsuit that used FDA Form 483 inspection reports to demonstrate that KV Pharmaceutical made false or misleading statements regarding its regulatory compliance can proceed even though inspection…

There’s little chance that FDA premarket clearance and Centers for Medicare & Medicaid Services coverage with evidence development (CED) decisions will be coordinated in the near future, Louis Jacques, director…