Attorney Nick Oberheiden lays out a 10-step strategy for companies to use in responding to an FDA Warning Letter.
FDA grants Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, and its use ...
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Four stakeholders make suggestions for an FDA draft guidance on using registries as part of real-world data in drug and biologic regulatory decision-m...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FDA publishes a finalized 2013 draft guidance on pre-launch activities importation requests.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.