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.
Federal Register notice: FDA announces a 9/27 Neurological Devices Panel meeting to review a Sequent Medical PMA for the Woven Endobridge Aneurysm Emb...
FDA Review posts the Federal Register notices for the week ending 8/17/2019.
An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver System finds elevate...
Federal Register notice: FDA extends the proposal period for its Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Ce...