FDA publishes a finalized 2013 draft guidance on pre-launch activities importation requests.
Federal Register notice: FDA makes available a final guidance entitled Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Developmen...
FDA puts a clinical hold on a Ceylad Oncology Phase 1b trial due to insufficient information to assess the risk to study subjects.
Former FDAer Timothy Cote asks FDA to suspend regulatory actions on all requests it has from Russian pharmaceutical and medical device companies.
FDA releases the FDA-483 with one observation issued following an inspection at OSRX, a Missoula, MT, sterile drug compounder.
FDA publishes the second in a planned series of four methodological guidances on patient-focused drug development.
Federal Register notice: FDA classifies the screw sleeve bone fixation device into Class 2.
FDA releases final guidance on CDRHs Appeals Processes that describes the processes available to stakeholders to seek supervisory review of decisions ...