Federal Register notice: FDA makes available a final guidance entitled Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Develo...
Four stakeholders make suggestions for an FDA draft guidance on using registries as part of real-world data in drug and biologic regulatory decision-m...
FDA says its clinical hold on a Finch Therapeutics Phase 3 trial of CP101 remains in place as the company responds to a request for information on its...
FDA publishes a finalized 2013 draft guidance on pre-launch activities importation requests.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.