USFDA Databases

FDA Adverse Event Reporting System (FAERS) monitors the safety of drugs & biologic products, contains reports of AE & medication errors that have been submitted to the FDA & to take appropriate action, such as updating drug labels/issuing safety communications. 

Bioequivalence (BE) Recommendations for Specific Products provides guidance on BE studies that helps applicants seeking approval for an ANDA to design their BE studies in accordance with FDA regulations & ensures that generic drugs are equivalent to their brand-name counterparts in terms of active ingredient, dosage form, strength, route of administration, & conditions of use.

Bioresearch Monitoring Information System (BMIS) provides information on clinical investigators, CROs, and IRBs involved in the conduct of IND studies with human INDs. It serves as a resource for both FDA & public to access information on the individuals and organizations involved in the r&d of new drugs.

Clinical Investigator Inspection List (CLIIL) provides information on inspections of clinical investigators who have performed studies with INDs. This is used by the FDA to track the compliance of clinical investigators with FDA regulations and to identify potential issues or concerns that may affect the validity of clinical trial data.

Dissolution methods database provides dissolution methods information that are currently recommended by the Division of BE, OGD for drug products that do not have a dissolution test method in the USP.

Drugs@FDA provides the information on FDA-approved brand name and generic Rx and OTC human drugs and biological therapeutic products. It provides patient information, labels, approval letters, reviews, and other important information. 


Inactive Ingredient Search for Approved Drug Products provides the information of inactive ingredients in approved drug products and important for patients to be aware of it in their medications, as they may have allergies or sensitivities to certain ingredients and ensure the safety of patients by providing them with information about them in their medications.


National Drug Code Directory provides the information on RXs and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution & is updated in accordance with the Drug Listing Act and regulatory provisions concerning the submission of DP information to the FDA. 


Orange Book (Approved Drug Products with Therapeutic Equivalence) provides the information on therapeutic equivalence, which is crucial for healthcare professionals and patients to make informed decisions about drug products. 


Postmarket Requirements and Commitments contains public access to information on postmarket requirements and commitments that FDA has made to sponsors of approved NDAs and BLAs & helps to ensure that drug manufacturers fulfill their postmarket obligations and commitments, thus ensuring the continued safety and effectiveness of drugs in the market.

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