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 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.

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 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.

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.

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.

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.

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).

This submission includes publicly available data extracted in its original form. Please reference the Related Publication listed here for source and citation information. FDA Recalls, Market Withdrawals, & Safety Alerts If you have questions about the underlying data stored here, please contact the FDA at https://www.fda.gov/about-fda/contact-fda. If you have questions about the metadata, please contact CAFE at climatecafe@bu.edu "Description: The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all recalls have press releases or are posted on this page." [Quote from: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts]

The Food and Drug Administration (FDA) conducts careful inspections of regulated facilities to determine a firm's compliance with regulations and the Food, Drug and Cosmetic Act.

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.

Clinicians prescribing therapeutic agents newly approved by the FDA must rely on the information reported through drug labels (also known as “package inserts”). Ideally, labels should incorporate details regarding key efficacy information, including the magnitude of treatment benefit, and measures of precision and random error (confidence intervals and p values). This study assessed the degree to which they actually provide this information. Original drug labels for all new molecular entities (NMEs) approved by the FDA between January 2015 and March 2018 were downloaded from the Drugs@FDA online database. NMEs not treating or preventing diseases or conditions and not tested in controlled trials were excluded. For each indication, the primary efficacy outcome was extracted and the presence or absence of the following attributes describing treatment effects were recorded: point estimates, confidence intervals, and p values. This dataset includes all data extracted and coded as well as copies of the original drug labels used in the study.

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This dataset is adapted from the paper Language Models Enable Simple Systems for Generating Structured Views of Heterogeneous Data Lakes. You can learn more about the data collection process there.
Please consider citing the following if you use this task in your work: @article{arora2024simple, title={Simple linear attention language models balance the recall-throughput tradeoff}, author={Arora, Simran and Eyuboglu, Sabri and Zhang, Michael and Timalsina, Aman and Alberti, Silas and… See the full description on the dataset page: https://huggingface.co/datasets/hazyresearch/based-fda.

The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) data package contains information on medication errors, quality complaints and drug-related adverse events that were submitted to FDA in 2021.

A mirror of all FDA guidance documents as found on Data captured on 2025-02-16 steps.txt details how the data was obtained. The interesting documents can be found with rg "Per a court order, HHS is required to restore this website"

Database that contains 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. Dates of Coverage: 1939-present Update frequency: Daily. Data imported from the Orange Book depends on its update frequency.

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.