FDA Related News

Guide on ClinicalTrials.gov Civil Money Fines

FDA issues a final guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.

Federal Register

FDA Amends 9/15 Pediatric Panel Meeting

Federal Register notice: FDA amends a 7/23 notice about a 9/15 Pediatric Advisory Committee meeting.

Federal Register

2 Device Guides for Performance-based Pathway

Federal Register notice: FDA makes available two final device-specific guidance documents for its Safety and Performance Based Pathway.

Medical Devices

FDA Device Shortage List During Covid-19

FDA posts a device shortage list of products determined to be in short supply during the Covid-19 pandemic.

Medical Devices

Appeals Court Rejects Bard Preemption Defense

The 9th Circuit Court of Appeals rejects device preemption arguments from C.R. Bard in a product liability lawsuit involving the companys G2 Intravasc...

Biologics

Panel Backs Mesoblast BLA for Graft Versus Host Disease

FDAs Oncologic Drugs Advisory Committee votes nine to one in favor of approving a Mesoblast BLA for Ryoncil (remestemcell-L) as a treatment for steroi...

Medical Devices

Safety and Performance Pathway Criteria

FDA issues the first two guidances with performance criteria for two medical device types to support the safety and performance-based pathway.

Human Drugs

Assessing Clinical Benefit with a Focus on Pain

CDER researchers discuss the regulatory approach to assessing clinical benefit with a focus on pain.

Human Drugs

FDA Position on Reporting Threshold in USP Monographs

FDA explains why it believes USP should not include disregard limits/reporting thresholds in any monograph revisions.

Medical Devices

Medical Device Covid FAQs

FDA issues two FAQ documents on medical device importing and registration/listing during the Covid-19 pandemic.