FDA Related News

Federal Register

Info Collection Extension on Emergency Use Authorization

Federal Register notice: FDA seeks comments on an information collection extension entitled Emergency Use Authorization of Medical Products.

Human Drugs

Trial Results Unlikely to Support sNDA Approval: FDA

FDA tells Karyopharm clinical trial results are unlikely to support approval of its selinexor as maintenance therapy for endometrial cancer patients f...

Federal Register

Guide on Older Adults in Cancer Trials

Federal Register notice: FDA posts a final guidance entitled Inclusion of Older Adults in Cancer Clinical Trials.

Medical Devices

J&Js Drug Eluting Contacts OKd for Allergy Eyes

FDA approves a Johnson & Johnson Vision Cares Acuvue Theravision with Ketotifen, a drug-eluting contact lens with the antihistamine ketotifen to help ...

Medical Devices

SurGenTecs Ion Screw Cleared for Spinal Fixation

FDA clears a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant.

Strategies for Responding to a Warning Letter

Attorney Nick Oberheiden lays out a 10-step strategy for companies to use in responding to an FDA Warning Letter.

Biologics

Breakthrough on Pfizer RSV Vaccine

FDA grants Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, and its use ...

Federal Register

Oncology Trial Master Protocols Guidance

Federal Register notice: FDA makes available a final guidance entitled Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Develo...

Human Drugs

Stakeholder Suggestions for FDA Registries RWD Guidance

Four stakeholders make suggestions for an FDA draft guidance on using registries as part of real-world data in drug and biologic regulatory decision-m...

Human Drugs

Finch Phase 3 C. Diff Trial Still on Hold: FDA

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...