FDA Drugs Database

**Overview**
This data package contains 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.

**Description**
Drugs at FDA is a database of FDA Approved Drug Products available in the FDA official website for search by drug name, active ingredient or application number. It provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997. Drugs@FDA contains prescription and over-the-counter human drugs and therapeutic biologicals currently approved for sale in the United States. Drugs@FDA includes discontinued drugs and "Chemical Type 6" approvals. Drugs@FDA contains the following therapeutic biological products:
- monoclonal antibodies
- cytokines, growth factors, enzymes, immunomodulators; and thrombolytics
- proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
- other non-vaccine therapeutic immunotherapies

**Benefits**
- The data package is useful for finding labels for approved drug products, generic drug products for an innovator drug product, therapeutically equivalent drug products for an innovator or generic drug product, consumer information for drugs, all drugs with a specific active ingredient, viewing the approval history of a drug.

**License Information**
The use of John Snow Labs datasets is free for personal and research purposes. For commercial use please subscribe to the [Data Library](https://www.johnsnowlabs.com/marketplace/) on John Snow Labs website. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

**Included Datasets**
- [Approved Risk Evaluation and Mitigation Strategies Materials Data](https://johnsnowlabs.com/wp-json/datasets-api/v1/approved-risk-evaluation-and-mitigation-strategies-materials-data)
- The Approved Risk Evaluation and Mitigation Strategies Materials (REMS) dataset includes data on all of the materials that have ever been part of a REMS program, including information on materials that are no longer subject to a Risk Evaluation and Mitigation Strategies (REMS).
- [Approved Risk Evaluation and Mitigation Strategies Products Data](https://johnsnowlabs.com/wp-json/datasets-api/v1/approved-risk-evaluation-and-mitigation-strategies-products-data)
- The Approved Risk Evaluation and Mitigation Strategies Products dataset includes data on all of the drugs that have ever been part of a REMS program, including information on products that are no longer marketed and/or no longer subject to a Risk Evaluation and Mitigation Strategies (REMS).
- [Clinical Investigator Inspection List](https://johnsnowlabs.com/wp-json/datasets-api/v1/clinical-investigator-inspection-list)
- 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.
- [Clinical Investigators Disqualification Proceedings](https://johnsnowlabs.com/wp-json/datasets-api/v1/clinical-investigators-disqualification-proceedings)
- The Clinical Investigators Disqualification Proceedings dataset lists clinical investigators who are or have been subject to an administrative clinical investigator disqualification action and indicates the current status of that action.
- [Drugs Application Number and Sponsor](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-application-number-and-sponsor)
- This dataset contains the Applications part to build the Drugs@FDA database. Drugs at FDA is a database of FDA Approved Drug Products available on the FDA official website. It provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997.
- [Drugs Application Submission Property Type](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-application-submission-property-type)
- This dataset contains the Application Submission Property Type part to build the Drugs@FDA database. Drugs at FDA is a database of FDA Approved Drug Products available on the FDA official website. It provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997.
- [Drugs Data File Document Addresses](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-data-file-document-addresses)
- This dataset contains the Application Documents part to build the Drugs@FDA database. Application Documents refers to "document addresses or URLs to letters, labels, reviews, Consumer Information Sheets, FDA Talk Papers, and other types. Drugs at FDA provides information of drug name, active ingredient, strength, application number, label info, dosage form or route, marketing status as well as patient information, approval letters, review and other facts for drugs approved after 1997.
- [Drugs Database Marketing Status](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-database-marketing-status)
- This dataset contains the Marketing Status part to build the Drugs@FDA database. Drugs at FDA is a database that provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997.
- [Drugs Database Products Included](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-database-products-included)
- This dataset contains the Product part to build the Drugs@FDA database. Drugs at FDA is a database of FDA Approved Drug Products available on the FDA official website. It provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997.
- [Drugs Database Submissions Included](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-database-submissions-included)
- This dataset contains the Application Submission part to build the Drugs@FDA database from the Food and Drug Administration (FDA) Approved Drug Products available on their official website. It provides information on drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status, and pharmaceutical company as well as patient information, approval letters, review and other facts for drugs approved after 1997.
- [Drugs Therapeutic Equivalence Code](https://johnsnowlabs.com/wp-json/datasets-api/v1/drugs-therapeutic-equivalence-code)
- This dataset contains the Therapeutic Equivalence Code part to build the Drugs@FDA database. Application Documents refers to "document addresses or URLs to letters, labels, reviews, Consumer Information Sheets, FDA Talk Papers, and other types. Drugs at FDA is a database of FDA Approved Drug Products. It provides information of drug (generic) name, active ingredient, form and strength available, FDA application number, label info, dosage form or route, marketing status and other facts.
- [FDA Drug Discontinuation](https://johnsnowlabs.com/wp-json/datasets-api/v1/fda-drug-discontinuation)
- The Food and Drug Administration (FDA) Drug discontinuation database includes information about current drugs in discontinuations of specific drug products, resource information, and relevant links.
- [FDA Drug Master Files Directory](https://johnsnowlabs.com/wp-json/datasets-api/v1/fda-drug-master-files-directory)
- This dataset contains a list of the Drug Master Files (DMF) submitted to the Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research (CDER) since 1900 to the current date. Drug Master Files are submitted by pharmaceuticals (holders) to the CDER providing confidential information on facilities, processes and articles implemented in the production of human drugs.
- [FDA Drug Shortages](https://johnsnowlabs.com/wp-json/datasets-api/v1/fda-drug-shortages)
- Food and Drug Administration (FDA) Drug Shortages includes information about current drugs in shortage and resolved shortages of specific drug products, resource information, and relevant links.
- [FDA Inspections Database](https://johnsnowlabs.com/wp-json/datasets-api/v1/fda-inspections-database)
- 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.

**Data Engineering Overview**
**We deliver high-quality data**
- Each dataset goes through 3 levels of quality review
- 2 Manual reviews are done by domain experts
- Then, an automated set of 60+ validations enforces every datum matches metadata & defined constraints
- Data is normalized into one unified type system
- All dates, unites, codes, currencies look the same
- All null values are normalized to the same value
- All dataset and field names are SQL and Hive compliant
- Data and Metadata
- Data is available in both CSV and Apache Parquet format, optimized for high read performance on distributed Hadoop, Spark & MPP clusters
- Metadata is provided in the open Frictionless Data standard, and its every field is normalized & validated
- Data Updates
- Data updates support replace-on-update: outdated foreign keys are deprecated, not deleted

**Our data is curated and enriched by domain experts**

Each dataset is manually curated by our team of doctors, pharmacists, public health & medical billing experts:
- Field names, descriptions, and normalized values are chosen by people who actually understand their meaning
- Healthcare & life science experts add categories, search keywords, descriptions and more to each dataset
- Both manual and automated data enrichment supported for clinical codes, providers, drugs, and geo-locations
- The data is always kept up to date – even when the source requires manual effort to get updates
- Support for data subscribers is provided directly by the domain experts who curated the data sets
- Every data source’s license is manually verified to allow for royalty-free commercial use and redistribution.

**Need Help?**
If you have questions about our products, contact us at [[e-mail]](mailto:[e-mail]).

搜集汇总

背景与挑战

背景概述

该数据集包含FDA批准的药物信息，涵盖处方药、非处方药和治疗性生物制品，提供药品名称、活性成分、批准历史等详细信息。数据集经过严格的质量审查，适用于研究和商业用途，需订阅获取商业使用权。