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.

An inventory of all FDA Datasets

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 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.

This dataset was obtained from https://open.fda.gov/data/downloads/. It is updated regularly by the FDA. Hence it is important to be aware that the dataset here is only up to 09/06/2022, the date of download. There are 25 fields in the original dataset with 22840 rows. The detailed description of some of the fields can be found here.

We provide the original json dataset, named as food-enforcement-0001-of-0001. For better accessibility we provide the converted csv file as the food_enforcement table. We created four other tables bio_contamination, chemical_contamination, material_contamination, and admin_failure, based on the reasons of the recall events. Finally, the combined table is the union of the four tables.

We note the bio_contamination, chemical_contamination, material_contamination, and the admin_failure tables are neither mutually exclusive nor mutually exhaustive. The overlaps accounts for less than two percent of the data. Moreover, the combined table has 21357 rows. Compared to the original dataset with 22840 rows, we still have a substantial amount of coverage. The remaining rows do not have obvious key words for easy categorification. More details can be found in the report.

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.

Contains data for FDA recalls from 2009 through the present.

FDA is disclosing the final inspection classification for inspections related to currently marketed FDA-regulated products. The disclosure of this information is not intended to interfere with planned enforcement actions, therefore some information may be withheld from posting until such action is taken.

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 data package contains medical datasets that have been used to build the Drugs@FDA. The information is classified by health information, regulatory information and advanced search. This data package contains the necessary technical information (excluding programming scripts) to reproduce the online version of Drugs@FDA. The data package is best to use with a database program.

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.

This data package contains the details of substances in drugs, biologics, foods and devices registered with a Unique Ingredient Identifier (UNII) through the joint FDA/USP Substance Registration System (SRS). It also contains a list of the names used for each UNII and the changes made to Unique Ingredient Identifiers' (UNIIs) descriptions to the latest update.

Data sets are extracted from the 2023 release of the e-Drug3D Database (2083 FDA-approved drug structures)

e-Drug3D_2083.zip (contains e-Drug3D_2083.sdf) - Chemical Structures - The e-Drug3D collection in SDF format file - one 3D conformer; ionization of carboxylic acid, phosphate, phosphonate, phosphonoamide, amidinium and guanidinium groups. The datablock contains the ID, name (INN), CAS number and Status.

e-Drug3D_2083_PK.csv - Pharmacokinetics - Column/field value is separated by a semicolon. It contains the e-Drug3D ID, INN (drug name), CAS number, year of approval, Status, is_or_has a metabolite, routes of administration, Volume of distribution (VD), Clearance (Cl), Plasma Protein Binding (PPB), Half-life (t1/2), Bioavailability (F), Cmax/Tmax, comment on solubility.

e-Drug3D_2083_PD.csv - Pharmacodynamics - Column/field value is separated by a semicolon. It contains the e-Drug3D ID, INN (drug name), CAS number, year of approval, Status, Primary target, ATC code(s), PDB codes and main list of drug targets.

e-Drug3D_2083_RD.csv - FDA Registration Data - Column/field value is separated by a semicolon. It contains the ID, name (INN), CAS number, First year of approval, Status, KNApSAcK or NPAtlas Id if natural product, all associated NDA numbers [FDA approval number, name of the label file in PDF format, company name, year of approval and commercial name of the drug] and the Indication/Therapeutic class information.

labels.tar.gz - The drug label files in PDF format (compressed directory). A label file is named with the NDA number. The NDA number is the approval number assigned by the FDA. A drug may possess several NDA numbers (see the above e-Drug3D-RD data set).

The FDA Device Dataset by Dataplex provides comprehensive access to over 24 million rows of detailed information, covering 9 key data types essential for anyone involved in the medical device industry. Sourced directly from the U.S. Food and Drug Administration (FDA), this dataset is a critical resource for regulatory compliance, market analysis, and product safety assessment regarding.

Dataset Overview:

This dataset includes data on medical device registrations, approvals, recalls, and adverse events, among other crucial aspects. The dataset is meticulously cleaned and structured to ensure that it meets the needs of researchers, regulatory professionals, and market analysts.

24 Million Rows of Data:

With over 24 million rows, this dataset offers an extensive view of the regulatory landscape for medical devices. It includes data types such as classification, event, enforcement, 510k, registration listings, recall, PMA, UDI, and covid19 serology. This wide range of data types allows users to perform granular analysis on a broad spectrum of device-related topics.

Sourced from the FDA:

All data in this dataset is sourced directly from the FDA, ensuring that it is accurate, up-to-date, and reliable. Regular updates ensure that the dataset remains current, reflecting the latest in device approvals, clearances, and safety reports.

Key Features:

• Comprehensive Coverage: Includes 9 key device data types, such as 510(k) clearances, premarket approvals, device classifications, and adverse event reports.

• Regulatory Compliance: Provides detailed information necessary for tracking compliance with FDA regulations, including device recalls and enforcement actions.

• Market Analysis: Analysts can utilize the dataset to assess market trends, monitor competitor activities, and track the introduction of new devices.

• Product Safety Analysis: Researchers can analyze adverse event reports and device recalls to evaluate the safety and performance of medical devices.

Use Cases: - Regulatory Compliance: Ensure your devices meet FDA standards, monitor compliance trends, and stay informed about regulatory changes.

• Market Research: Identify trends in the medical device market, track new device approvals, and analyze competitive landscapes with up-to-date and historical data.

• Product Safety: Assess the safety and performance of medical devices by examining detailed adverse event reports and recall data.

Data Quality and Reliability:

The FDA Device Dataset prioritizes data quality and reliability. Each record is meticulously sourced from the FDA's official databases, ensuring that the information is both accurate and up-to-date. This makes the dataset a trusted resource for critical applications, where data accuracy is vital.

Integration and Usability:

The dataset is provided in CSV format, making it compatible with most data analysis tools and platforms. Users can easily import, analyze, and utilize the data for various applications, from regulatory reporting to market analysis.

User-Friendly Structure and Metadata:

The data is organized for easy navigation, with clear metadata files included to help users identify relevant records. The dataset is structured by device type, approval and clearance processes, and adverse event reports, allowing for efficient data retrieval and analysis.

Ideal For:

• Regulatory Professionals: Monitor FDA compliance, track regulatory changes, and prepare for audits with comprehensive and up-to-date product data.

• Market Analysts: Conduct detailed research on market trends, assess new device entries, and analyze competitive dynamics with extensive FDA data.

• Healthcare Researchers: Evaluate the safety and efficacy of medical devices product data, identify potential risks, and contribute to improved patient outcomes through detailed analysis.

This dataset is an indispensable resource for anyone involved in the medical device industry, providing the data and insights necessary to drive informed decisions and ensure compliance with FDA regulations.

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.

This blog post was posted on September 4, 2015 and written by Taha Kass-Hout, M.D., M.S., Roselie A. Bright, Sc.D., M.S., P.M.P. and Ann Ferriter. It is a cross post from FDA Voice.

The CDRH Inspections Database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present.

This dataset tracks the updates made on the dataset "Drugs@FDA Database" as a repository for previous versions of the data and metadata.

This dataset tracks the updates made on the dataset "FDA Data Inventory" as a repository for previous versions of the data and metadata.

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