FDA Related News

Medical Devices

LivaNova Blood-Gas Monitor for Heart-lung Machine

FDA clears a LivaNova 510(k) for B-Capta, an in-line, blood-gas monitoring system integrated into its S5 heart-lung machine.

Medical Devices

J&J Cataract Surgical Device Cleared

FDA clears a Johnson & Johnson Vision 510(k) for its Veritas Vision System, a phacoemulsification (cataract surgery) device that allows surgeons to gu...

FDA Should Disclose Confidential Drug, Vaccine Data: Article

Two Yale Law School professors suggest changes to FDA to create a clinical trial publicity regime exposing confidential data.

Biologics

FDA HCT/P Enforcement Discretion Ending 5/31: Marks

CBER director Peter Marks says enforcement discretion for IND and premarket application requirements for certain regenerative medicine products will n...

Biologics

Allogene Myeloma Therapy Gains Regenerative Medicine Status

FDA grants Allogene Therapeutics a Regenerative Medicine Advanced Therapy designation for ALLO-715 and its use in relapsed/refractory multiple myeloma...

Human Drugs

ICH Publishes E6 Good Clinical Practice Draft

The International Council for Harmonization publishes a draft version of its E6 good clinical practice guideline.

Biologics

EMA Adds Warning to J&J Vaccine; Supports Use

A European Medicines Agency safety review says Johnson & Johnsons Covid-19 vaccine continues to have a favorable benefit-risk profile but it should ca...

Human Drugs

KalVista Trial in Hereditary Angioedema on Hold

FDA places a clinical hold on a KalVista Pharmaceuticals proposed Phase 2 clinical trial of KVD824 for preventing hereditary angioedema attacks.

Medical Devices

Medtronic Bio-Console 560 Perfusion System Recall Class 1

FDA says a Medtronic recall of 93 units of its Bio-Console 560 blood pumping console due to potential electrical failure is Class 1.

Human Drugs

Topics Discussed at 2 PDUFA 7 Pre-Market Subgroup Meetings

FDA releases summaries of two PDUFA 7 negotiating sessions by the FDA/industry pre-market subgroup.