FDA clears a Techlab 510(k) for the H. Pylori Quik Chek and the H. Pylori Chek tests that are intended to aid in diagnosing H. pylori infection.
FDA releases its latest batch of Warning Letters that include Hangzhou Karic Commodities and Kyowa Hakko Bio.
FDA clears a UVision360 510(k) for the Luminelle DTx Hysteroscopy for use in both hysteroscopy and cystoscopy procedures.
FDA grants Audentes Therapeutics a regenerative medicine advanced therapy designation for AT132 and its use in treating X-linked myotubular myopathy.
FDA posts a guidance on Quality Attribute Considerations for Chewable Tablets that provides the agencys current thinking on the critical quality attri...
FDA posts a guidance on Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.
Federal Register notice: FDA extends the comment period for a previous notice about study designs intended to generate data to support substantial evi...
Federal Register notice: FDA submits to OMB an information collection extension for Samples and Protocols.