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...

Medical Devices

Clarify What SiMD is Included in SaMD Plan: AdvaMed

AdvaMed says FDA should apply the same policies to software in a medical device that it applies to software as a medical device.

Medical Devices

7 Topics Discussed at 2nd MDUFA 5 Reauthorization Meeting

FDA releases a summary of discussions on seven topics at the second MDUFA 5 reauthorization negotiation meeting.

Human Drugs

5 Reps Bill Would End Mandatory Animal Testing

A bipartisan group of House members introduces legislation to end mandatory animal testing in drug development.

Medical Devices

FDA Eases Pooled Serial Screening Claims for Covid Tests

FDA eases possible pooling of some Covid test nasal specimens in serial testing programs.

Human Drugs

Y-mAbs Submitting Omburtamab Data Sought by FDA

Officials of Y-mAbs Therapeutics say they are collecting additional omburtamab data sought by FDA to be able to agree on a statistical analysis plan.