National Academies of Sciences%2c Engineering%2c and Medicine

Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report

To gain a foundation on which to build its discussions, the committee commissioned two former Center for Devices and Radiological Health (CDRH) staff to draft a background paper on the 510(k) or ...
Yahoo

Years after warning from FDA, Nephron sees ‘egregious’ violations in inspection

Add Yahoo as a preferred source to see more of our stories on Google. Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of ...
Food Safety News

FDA warns sprout producer about serious food safety violations

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...
MobiHealthNews

Q&A: What FDA layoffs mean for MedTech approvals

Mass layoffs at the U.S. Department of Health and Human Services (HHS), including the Food and Drug Administration (FDA), will impact the medical device regulatory process, says Ben Wolf, partner in ...
MarketWatch

Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing

Kemwell Biopharma Pvt Ltd ("Kemwell"), a leading global biologics Contract Development and Manufacturing Organization (CDMO), announced today that its drug-product manufacturing facility in Bengaluru ...
Nasdaq

Capricor Therapeutics Announces Successful FDA Pre-License Inspection and Upcoming Advisory Committee Meeting for Deramiocel in Duchenne Muscular Dystrophy Treatment

Capricor Therapeutics announced that it has successfully completed the U.S. FDA's Pre-License Inspection of its San Diego manufacturing facility for its lead therapy candidate, Deramiocel, aimed at ...