35 datasets found for "Safety"
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Federal
Premarket Approvals (PMA)
U.S. Department of Health & Human Services —
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An... -
Federal
Premarket Notifications (510(k)s)
U.S. Department of Health & Human Services —
Medical device manufacturers are required to submit a premarket notification or 510(k) if they intend to introduce a device into commercial distribution for the first... -
Federal
FDA Adverse Event Reporting System (FAERS): Latest Quartely Data Files
U.S. Department of Health & Human Services —
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is... -
Federal
Approved Animal Drug Products (Green Book)
U.S. Department of Health & Human Services —
On November 16, 1988, the President of the United States signed into law the Generic Animal Drug and Patent Restoration Act (GADPTRA). Among its major provisions, the... -
Federal
FDA Recognized Consensus Standards
U.S. Department of Health & Human Services —
This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information... -
Federal
Approved Drug Products with Therapuetic Equivalence Evaluations (Orange Book)
U.S. Department of Health & Human Services —
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book) identifies drug products approved on the... -
Federal
All FDA Recalls
U.S. Department of Health & Human Services —
Contains data for FDA recalls from 2009 through the present. -
Federal
Drugs to be Discontinued
U.S. Department of Health & Human Services —
Companies are required under Section 506C of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (as amended by the Food and Drug Administration Safety and... -
Federal
Enforcement Reports
U.S. Department of Health & Human Services —
Whereas not all recalls are announced in the media or on our Recalls press release page, all recalls montiored by FDA are included in FDA's weekly Enforcement Report... -
Federal
Adverse Event Reporting System (AERS)
U.S. Department of Health & Human Services —
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all... -
Federal
FDA Online Label Repository
U.S. Department of Health & Human Services —
The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug... -
Federal
Health Information Updates
U.S. Department of Health & Human Services —
This feed provides new health and safety updates related to FDA approved products -
Federal
Recalls of Medical Devices
U.S. Department of Health & Human Services —
This database contains a list of classified medical device recalls since November 1, 2002 -
Federal
POCA -Phonetic Orthographic Computer Algorithm
U.S. Department of Health & Human Services —
POCA is a software that produces a data set used internally to assess the safety, and feasibility of proposed proprietary drug names. FDA product name safety... -
Federal
MedSun Reports
U.S. Department of Health & Human Services —
The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002. The primary goal for MedSun is to work collaboratively with the... -
Federal
FDA Pet Food Recalls
U.S. Department of Health & Human Services —
Contains data for FDA pet food recalls since January 1, 2006. -
Federal
MDR (Medical Device Reporting)
U.S. Department of Health & Human Services —
This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the... -
Federal
MedWatch Safety Alerts for Human Medical Products
U.S. Department of Health & Human Services —
MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts... -
Federal
Fraudulent 2009 H1N1 Influenza Products Widget
U.S. Department of Health & Human Services —
This list is intended to alert consumers about Web sites that are or were illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009... -
Federal
FDA Peanut-Containing Product Recall
U.S. Department of Health & Human Services —
The FDA Peanut-Containing Product Recall widget allows you to browse the Food and Drug Administration (FDA) database of peanut butter and peanut-containing products...
35 datasets found for "Safety"