An inventory of all FDA Datasets

Information about FDA-approved brand name and generic prescription and over-the-counter human drugs and biological therapeutic products. Drugs@FDA includes most of the drug products approved since 1939. The majority of patient information, labels, approval letters, reviews, and other information are available for drug products approved since 1998.

This file contains the data elements used for searching the FDA Online Data Repository including proprietary name, active ingredients, marketing application number or regulatory citation, National Drug Code, and company name.

This database consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission. Information submitted on conformance with such standards will have a direct bearing on safety and effectiveness determinations made during the review of IDEs, HDEs, PMAs, and PDPs. Conformance with recognized consensus standards in and of itself, however, may not always be a sufficient basis for regulatory decisions.

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 Administration (FDA). (See 21 CFR part 207.) The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Drugs marked 'OTC monograph final' or OTC monograph not final' are not checked for conformance to the monograph. Drugs marked 'unapproved medical gas', 'unapproved homeopathic' or 'unapproved drug other' on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.

Homeland Infrastructure Foundation-Level Data (HIFLD) geospatial data sets containing information on Food and Drug Administration (FDA) Office Facilities.

Information provided to FDA by manufacturers about current drugs in shortage, resolved shortages, and discontinuations of specific drug products.

Contains data for FDA recalls from 2009 through the present.

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 designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.

This database contains medical device names and associated information developed by the Center. It includes a three letter device product code and a Device Class that refers to the level of CDRH regulation of a given device.

The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities

Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which they actually provide this information. Original drug labels for all new molecular entities (NMEs) approved by the FDA between January 2015 and March 2018 were downloaded from the Drugs@FDA online database. NMEs not treating or preventing diseases or conditions and not tested in controlled trials were excluded. For each indication, the primary efficacy outcome was extracted and the presence or absence of the following attributes describing treatment effects were recorded: point estimates, confidence intervals, and p values. This dataset includes all data extracted and coded as well as copies of the original drug labels used in the study.

Contains data for FDA pistachio product recalls since March 2009.

This searchable database contains establishments (engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of medical devices intended for human use and commercial distribution) and listings of medical devices in commercial distribution by both domestic and foreign manufacturers. Note: This database is updated once a week.

This dataset includes the Premarket Approval (PMA) data which is the Food and Drug Administration (FDA) process of scientific and regulatory review to assess the safety and effectiveness of Class III medical devices. These devices support human life and prevent impairment of human health. Due to the level of risk associated with Class III devices, general and special controls are insufficient to assure the safety of these devices and require a PMA application to obtain marketing clearance.

Contains data for FDA shell egg recalls.

This dataset represents all technologies available for licensing from the National Institutes of Health (NIH), the Food and Drug Administration (FDA), and the Center for Disease Control and Prevention (CDC).

Contains data for FDA peanut product recalls since January 2009.

The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. You can search the TPLC database by device name or procode to receive a full report about a particular product line.

Contains data for FDA pet food recalls since January 1, 2006.