In order to foster transparency and encourage information sharing within the clinical research community, FDA’s Center for Drug Evaluation and Research (CDER) maintains a bioresearch monitoring Web site that makes certain clinical research information available to the public. 

This Web site contains information on clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of clinical studies conducted under an Investigational New Drug (IND) application with human investigational drugs and therapeutic biologics which are listed on a Form FDA 1572 submitted to CDER.  BMIS is, therefore, not intended to provide a comprehensive list of all CIs, CROs, or IRBs involved in clinical research. 

The Clinical Investigator Inspection List (CLIIL) contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs. The Clinical Investigator Inspection List (CLIIL) database contains information on clinical investigator inspections conducted since October 1, 2008, and that have a final classification. 

The clinical investigator inspections were conducted as part of the Food and Drug Administration's Bioresearch Monitoring Program (BIMO) within the Center for Drug Evaluation and Research (CDER). The BIMO program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

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.

The drug establishments' current registration site is a publication of currently registered establishments that manufacture, prepare, propagate, compound, or process drugs that are distributed in the U.S. or offered for import to the U.S.

The Drug Safety-related Labeling Changes (SrLC) database includes updates to safety information in the labeling for human prescription drugs regulated under NDAs and human prescription biological products regulated under BLAs.  

FDA created this searchable database to provide stakeholders with easy access to information about drugs in shortage, such as product availability, supply, and estimated duration of shortage. The database includes information about current drugs in shortage, resolved shortages, discontinuations of specific drug products, corresponding therapeutic categories, resource information, and relevant links.

[email protected] contains information about the following FDA-approved products for human use:

• Prescription brand-name drug products, generic drug products, and many therapeutic biological products
• Over-the-counter brand-name and generic drugs

[email protected] 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.

The FDA Adverse Event Reporting System (FAERS) is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events that were submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.

The Inactive Ingredient Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product.

Medication Guides are paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

FDA’s National Drug Code (NDC) Directory contains information about finished drug products, unfinished drugs and compounded drug products.

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.

OTC [email protected] provides a resource for the public to view Administrative Orders (Proposed, Final, and Interim Final Orders) for OTC Monograph Drugs and view OTC Monographs. OTC [email protected] also facilitates the ability for the public to submit, search, and view comments and data for Proposed and Interim Final Administrative Orders, except if otherwise specified.

Outsourcing facilities are required to provide FDA with a list of drugs they compounded during the previous six-month period upon initial registration and in June and December each year. This database contains information reported to FDA since 2019. This information may be used to identify outsourcing facilities that have produced certain drugs.

Provides information to the public on postmarket requirements and commitments. The phrase postmarket requirements and commitments refer to studies and clinical trials that sponsors conduct after approval to gather additional information about a product's safety, efficacy, or optimal use. Some of the studies and clinical trials may be required; others may be studies or clinical trials a sponsor has committed to conducting.

Search for information about tentatively approved and approved antiretroviral drugs that are eligible for procurement under the President’s Emergency Plan for AIDS Relief (PEPFAR) Program.

To further facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific guidances describing the agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference listed drugs.

The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products and their reference products. 

The Purple Book also contains information about all FDA-licensed allergenic, cellular, and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).

The Drug Supply Chain Security Act (DSCSA) requires wholesale distributors and third-party logistics providers to report licensure and other information to FDA annually under sections 503(e)(2) and 584 Federal Food, Drug, and Cosmetic Act.