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Postmarket Drug and Biologic Safety Evaluations

This website provides summary information about ongoing and completed postmarket safety evaluations of adverse experience reports made to FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs) approved since September 27, 2007. The evaluations are done to de ....

MDR Overview

Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions. Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety i ....

Based on FDA outreach efforts and public comments, the FDA is proposing revisions to its proposed rule on foreign supplier verification programs intended to provide more flexibility in determining appropriate verification measures based on food and supplier risks.

Commenting

The FDA is accepting comments on the r ....

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), sign ....

Postmarket Drug and Biologic Safety Evaluations

Medical Device Reporting (MDR)-overview and reporting requirements

FSMA Proposed Rule for Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals

Background on the FDA Food Safety Modernization Act

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