Search results
Results from the WOW.Com Content Network
This guidance focuses on expedited safety reporting requirements for human drug and biological products that are being investigated under an IND and for drugs that are the subjects of bioavailability (BA) and bioequivalence (BE) studies that are exempt from the IND requirements. FDA: Adverse Event Reporting to IRBs. [26]
The FDA Adverse Event Reporting System (FAERS or AERS) is a computerized information database designed to support the U.S. Food and Drug Administration's (FDA) postmarketing safety surveillance program for all approved drug and therapeutic biologic products.
Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and devices in diverse populations as part of a purge of diversity, equity ...
Postmarketing surveillance is overseen by the Food and Drug Administration (FDA), which operates a system of passive surveillance called MedWatch, to which doctors or the general public can voluntarily report adverse reactions to drugs and medical devices. [7] The FDA also conducts active surveillance of certain regulated products.
The FDA had proposed that companies testing new anti-amyloid drugs exclude any volunteer from clinical trials who had more than two brain microbleeds, according to an Alzheimer's Assn. report.
MedWatch is the Food and Drug Administration’s “Safety Information and Adverse Event Reporting Program.” It interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event. Founded in 1993, this system of voluntary reporting allows such information to be shared with ...
The FDA on Tuesday and Wednesday posted notices about warning letters sent to companies and a drug safety notice. AP health writer Matthew Perrone in Washington contributed to this report.