FDA clears an Alfa Scientific Designs 510(k) for its Simple Cup multi-drug test with Driven Flow, a multi-drug of abuse urine test.
Federal Register notice: FDA makes available a draft guidance on Standardization of Data and Documentation Practices for Product Tracing.
Federal Register notice: FDA makes available a guidance entitled E18 Genomic Sampling and Management of Genomic Data.
FDA accepts for review a Jazz Pharmaceuticals NDA for solriamfetol, an investigational medicine for treating excessive sleepiness in adult patients wi...
Federal Register notice: FDA announces a regional public meeting entitled U.S. Food and Drug Administration and Health Canada Joint Regional Consultat...
Two attorneys say FDA is forcing some drug manufacturing outside the U.S. through its interpretation of rules governing API imports.
FDA posts an International Council for Harmonization guidance E18 Genomic Sampling and Management of Genomic Data.
FDA chooses Booz Allen Hamilton for part of a seven-year $300 million blanket purchase agreement to support implementation of an informatics platform ...