FDA Related News

Human Drugs

Questions Raised Again About Accelerated Approvals

The Los Angeles Times raises concerns about FDAs use of accelerated approval pathways for many new drugs.

Device, Drug Recalls Down in 2021: Sedgwick

The Sedgwick recall index for 2021 shows that both medical devices and drugs had fewer recalls and the recalls involved more units.

Human Drugs

FDA 2021 Personalized Medicine Milestones

The Personalized Medicine Coalition says FDA is accelerating its involvement in personalized medicine.

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 ...