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FDA
The search engine on the FDA Website will not find information that is in the databases that make up a large part of the site. Those databases can be accessed separately, using the links below. Following each link is a brief description of the database.
FDA Approved Animal Drug Products
Description: A listing of searchable databases in the following categories:
Approved Animal Drug Products (Basic search), Approved Animal Drug Products
(Advanced search), Suitability Petitions, Sponsors, Green Book, Code of Federal
Regulations, Federal Register, Patents, and Exclusivity.
FDA BSE/Ruminant Feed Inspections Firms Inventory
Description: Inspection information of renderers, feed mills, ruminant feeders, protein blenders, pet food manufacturers, pet food salvagers, animal feed distributors and transporters, ruminant feeders, and others regarding compliance with the BSE/Ruminant Feed regulations.
Adverse Event Reporting System
Description: The Adverse Event Reporting System is a computerized information database designed
to support the FDA's post-marketing safety surveillance program for all approved
drug and therapeutic biologic products.
Biological
Product Deviation Reports (BioDev)
Description: Records Incoming Biological Product Deviation Reports for CBER.
Vaccine Adverse Event Reporting System (VAERS)
Description: VAERS is a cooperative program for vaccine safety of the Centers for Disease
Control and Prevention (CDC) and the Food and Drug Administration (FDA).
VAERS collects information about adverse events that occur after the administration
of U.S. licensed vaccines.
Adverse Event Reporting System
Description: The Adverse Event Reporting System is a computerized information database designed
to support the FDA's post-marketing safety surveillance program for all approved
drug and therapeutic biologic products.
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Description: Listing of drug products approved on the basis of safety and effectiveness
by the FDA under the Federal Food, Drug, and Cosmetic Act.
Bioresearch Monitoring Information System (BMIS)
Description: The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs.
Clinical Investigator Inspection List (CLIIL)
Description: The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs.
Dissolution Methods Database
Description: For a drug product that does not have a dissolution test method in the United States Pharmacopeia (USP), the FDA Dissolution Methods Database provides information on dissolution methods presently recommended by the Division of Bioequivalence, Office of Generic Drugs.
Drugs@FDA
Description: A searchable and browsable catalog of information about 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. Search by drug name or active ingredient.
Drug Firm Annual Registration Status
Description: Allows firms manufacturing drug products to register the site where
the product was made within 5 days of commercial distribution and re-register
annually, updating and validating current site information as required by section
510 of the Federal Food, Drug, and Cosmetic Act and the Code of Federal Regulations
21 CFR part 207.
Inactive Ingredient Search for Approved Drug Products
Description: Database provides ability to search for inactive ingredients in approved drug products.
National Drug Code Directory
Description: The NDC serves as universal product identifier for human drugs.
Oncology Tools
Description: Provides several tools relating to the use of oncology drugs.
Postmarketing Study Commitments
Description:
Provides information to the public on postmarketing study commitments, also called phase 4 commitments. Postmarketing study commitments are studies — required of or agreed to by a sponsor — that are conducted after FDA has approved a product for marketing (e.g., studies requiring the sponsor to demonstrate clinical benefit of a product following accelerated approval). FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use.
The Seafood List
Description: A compilation of existing acceptable market names for imported
and domestically available seafood as well as scientific names, common names,
and known vernacular or regional names.
510(k)s--Premarket Notifications (PMN)
Description: This database of releasable 510(k)s can be searched by 510(k) number,
applicant, device name or FDA product code. Summaries of safety and effectiveness
information is available via the web interface for more recent records.
Advisory Committee/Panel Meetings
Description: Contains information about upcoming CDRH Advisory Committee and
Panel meetings. Historical information and links to summaries and/or transcripts
are provided for recent past meetings.
Assembler Database
Description: Federal regulations require that an assembler who installs one
or more certified components of a diagnostic x-ray system submit a report of
assembly. This database contains the releasable information submitted including
Equipment Location, General Information and Component Information. Note: Data
does no include dental system installations.
CDRH Document Database (index to the Center for Devices and Radiological
Health Web Pages)
Description: Produces CDRH topic index on demand.
Clinical Laboratory Improvement Amendments (CLIA) Database
Description: Contains the commercially marketed in vitro test systems categorized
by the FDA since January 31, 2000 and test categorized by the Centers for Disease
Control and Prevention (CDC) prior to that date.
Device Listing
Description: This database contains a listing of medical devices in commercial
distribution by both domestic and foreign manufacturers.
Establishment Registration
Description: This is a searchable database of domestic establishments engaged
in the manufacture, preparation, propagation, compounding, assembly, or processing
of medical devices intended for human use and commercial distribution.
Good Guidance Practice
Description: Contains the current comprehensive list of all CDRH guidance documents.
The term guidance document refers to documents prepared for CDRH staff, regulated
industry and the public that relate to the processing, content, and evaluation
of regulatory submissions; the design, production, manufacturing, and testing
of regulated products; or to the inspection and enforcement procedures.
Mammography Quality Standards Act - MQSA
Description: Allows users to access a listing by state and zip code of all mammography
facilities certified by the FDA as meeting baseline quality standards for equipment,
personnel and practices under the Mammography Quality Standards Act of 1992.
MAUDE
Description: MAUDE data represents reports of adverse events involving medical
devices. The data consists of all voluntary reports since June, 1993, user facility
reports since 1991, distributor reports since 1993, and manufacturer reports
since August, 1996.
Medical Device Approvals
Description: Products listed include some of the newest medical technology available.
Each product listing contains information about what medical usese the device
is approved for, when it can be used, and when it should not be used.
Medical Device Reporting
Description: Allows users to search for information on medical devices which
may have malfunctioned or caused a death or serious injury during years 1992
through 1996.
National Health Related Items Code (NHRIC)
Description: The National health Related Items code (NHRIC) is a system for
identification and numbering of marketed device packages that is compatible
with other numbering systems such as the National Drug Code (NDC) or Universal
Product Code (UPC).
Premarket Approval (PMA)
Description: Users can search for information on premarket approval status of
manufacturers.
Products Classification
Description: Contains medical device names and associated information. Users
can search this database by either medical specialty or name of device.
Recognized Consensus Standards Search
Description: 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 an of itself, however, may not always be a sufficient basis for
regulatory decisions.
Y2K Biomedical Equipment Clearing House
Description: This database and search mechanism permits the searching for the
Y2K status of biomedical equipment.
Description: Allows users to build valid FDA product codes. The Product Code Builder Application will guide you through an easy and user friendly selection process that will assist you in locating and building a product code. By building upon the code portions you select, the application will provide you with valid choices for each of the five components of the product code (industry, Class, Subclass, PIC, and Product).
CFR
Title 21 - Food and Drugs
Description: This database contains the most recent revision from the Government Printing Office (GPO) of the Code of Federal Regulations (CFR) Title 21 - Food and Drugs. You can search CFR Title 21 by entering a part and section number, selecting a CFR part number from a drop down list, or by using a full text search. The database will be updated on an annual basis.
Federal
Register
Description: Administers, searches and retrieves Federal Register Notices.
Warning Letters
Description: Allows users to search for warning letters by company, subject,
issuing office, date, using search form.