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Databases on the CDER Website
- Acronyms and Abbreviations
Description: The FDA Acronyms and Abbreviations database provides a quick reference to acronyms and abbreviations related to Food and Drug Administration (FDA) activities.
Update frequency: Monthly
Search the Database: http://www.accessdata.fda.gov/scripts/cder/acronyms/index.cfm
Introduction
About the Downloadable Data File
- Adverse Event Reporting System (AERS)
Description: The Adverse Event Reporting System supports the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biologic products. It contains adverse drug reaction reports FDA has received from manufacturers as required by regulation. We provide downloadable files only; you cannot search the database online.
Search the Database: http://www.fda.gov/cder/aers
Dates of Coverage: January 2004-present
Update Frequency: Quarterly
Introduction
About the Downloadable Data File
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Description: The Orange Book lists drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.
Search the Database: http://www.fda.gov/cder/orange
Update Frequency: Daily for new generic drug approvals and patent information; Monthly for other information.
Introduction
Frequently Asked Questions (FAQ)
About the Downloadable Data File
- 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.
Search the Database: http://www.accessdata.fda.gov/scripts/cder/bmis
Update frequency: Quarterly
Introduction
About the Downloadable Data File
- 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.
Search the Database: http://www.accessdata.fda.gov/scripts/cder/cliil
Dates of Coverage: August 1977-present
Update frequency: Quarterly
Introduction
About the Downloadable Data File
- 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.
Search the Database: http://www.accessdata.fda.gov/scripts/cder/dissolution
Update frequency: Quarterly
Frequently Asked Questions (FAQ)
- Drugs@FDA
Description: 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.
Search the Database: http://www.fda.gov/drugsatfda
Dates of Coverage: 1939-present
Update frequency: Daily. Data imported from the Orange Book depends on its update frequency.
Frequently Asked Questions (FAQ)
About the Downloadable Data File
- Drug Firm Annual Registration Status
Description: The Drug Firm Annual Registration Status database allows you to search for information submitted by drug firms to register sites where their products are made.
Search the Database: http://www.fda.gov/cder/dfars
Update frequency: Monthly
Frequently Asked Questions (FAQ)
- Inactive Ingredient Search for Approved Drug Products
Description: Database provides ability to search for inactive ingredients in approved drug products.
Search the Database: http://www.accessdata.fda.gov/scripts/cder/iig
About the Downloadable Data File
Update frequency: Quarterly
Frequently Asked Questions (FAQ)
- National Drug Code Directory
Description: The NDC serves as universal product identifier for human drugs.
Search the Database: http://www.fda.gov/cder/ndc/database
Update frequency: Monthly
Frequently Asked Questions (FAQ)
About the Downloadable Data File
- Oncology Tools
Description: Provides information on approved cancer drugs with approved indications.
Search the Database: http://www.fda.gov/cder/cancer/oncrefto.htm
Dates of Coverage: 1949-present
Update frequency: Approximately monthly, depending on whether there are any approvals.
Introduction
Approved Oncology Drugs with Approved Indications
- Orange Book See: Approved Drug Products with Therapeutic Equivalence Evaluations
- 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.
Search the Database: http://www.accessdata.fda.gov/scripts/cder/pmc
Dates of Coverage: January 15, 1999-present
Update frequency: Quarterly
Introduction
Frequently Asked Questions (FAQ)
About the Downloadable Data File
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Date created: October 24, 2007; Last updated: May 9, 2008 |
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