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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 Unique Ingredient Identifier (UNII) is an alphanumeric identifier linked to a substance's molecular structure or descriptive information and is generated by the Global Substance Registration System (GSRS) of the Food and Drug Administration (FDA).
The Food and Drug Administration Modernization Act of 1997 (Public Act 105-115) [4] amended the Food, Drug and Cosmetic Act and the Public Health Service Act to require that the NIH create and operate a public information resource, which came to be called ClinicalTrials.gov, tracking drug efficacy studies resulting from approved Investigational ...
FDA SRS Food and Drug Administration Substance Registration System U.S. National Library of Medicine: ingredients in FDA regulated products UNII inchikey "FDA SRS". 781,000 FEMA Flavor Ingredient Library: Flavor and Extract Manufacturers Association: CAS CFR FEMA number "FEMA". FooDB: Food Database University of Alberta Food components and ...
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...