MedPage Today

Goodbye FAERS? FDA Launches New Combined Adverse Event Database

The FDA has launched a new adverse event reporting system that will consolidate several systems it has for reporting different types of adverse events, the agency announced Wednesday. The new system, ...
MedTech Dive

FDA to unify agency’s ‘fragmented’ safety surveillance system

Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.
FierceBiotech

FDA opens door to massive real-world datasets in medical device submissions

The FDA said it plans to accept new forms of real-world evidence in product applications, starting with a subset of medical device submissions. The agency said the policy change aims to enable the use ...
California Healthline

Lawmakers Ask FDA To Alter Device Safety Databases

On Wednesday, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) sent a letter asking FDA to overhaul two databases that provide public information about medical device safety. The letter ...
MD&M East

FDA Acknowledges New AAMI Standards for Medical Device Sterilization

FDA has amended its database of Recognized Consensus Standards to include revised versions of sterility assurance and sterilization documents previously recognized in December of 2024. The new entry ...