WASHINGTON - The Food and Drug Administration has launched what it is describing as a "unified dashboard" for identifying and ...

FDA launches new AI-powered system to track drug and vaccine side effects in real time, replacing outdated databases and saving $120 million annually.

Yesterday, the Food and Drug Administration (FDA) announced the launch of the Adverse Event Monitoring System ( AEMS ), a new platform for assessing adverse event reports made to the FDA for drugs, ...

System will replace safety databases monitoring drugs, devices, food, and more ...

March 11 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has introduced a unified platform designed to ...

BIO's Crowley warns U.S. risks losing lead, a familiar red flag with Aldeyra, and other biotech news from The Readout ...

The AI adverse event problem nobody is talking about reveals risks in FDA-cleared surgical devices lacking robust clinical trials.

The FDA has issued a warning letter to Novo Nordisk for violating postmarketing adverse drug experience regulations that include failure to report adverse events among patients taking GLP-1s. In the ...

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is bringing sweeping changes to the cosmetics industry. One such change requires a “responsible person” to maintain and submit certain ...

Please provide your email address to receive an email when new articles are posted on . Women with vs. without cancer had similar serious adverse event risk after fertility preservation. Younger age, ...