## Overview

This data package consists of very informative FDA datasets, the details of which are as follows: The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs. Another dataset is a directory of the different biotech and biopharmaceutical and pharmaceutical companies in the United States and the European Union. A database of information submitted by drug firms to register establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S. Another dataset contains information submitted by wholesale distributors and third-party logistics providers (3PLs) to FDA. FDA inspections database contains inspections of establishments that manufacture, process, pack, or hold FDA-regulated products, before approving products and/or after products are on the market, to determine the establishment’s compliance with laws administered by FDA.

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## 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://aws.amazon.com/marketplace/pp/prodview-ou2apz7asjdai?sr=0-13&ref_=beagle&applicationId=AWSMPContessa#offers) on AWS. The subscription will allow you to use all John Snow Labs datasets and data packages for commercial purposes.

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## Metadata

Description | Value

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Data Package Complexity | Medium

Available Enrichments | N/A

Keywords | BIMO, List of Pharma Companies, Facilities Registration, 3PL Contract, FDA Acronyms, Post-Marketing, Clinical trials, Drug Manufacturing Companies, List of Biotech Companies, Biotech and Pharma Companies

Other Titles | US and EU Biopharmaceutical Companies, US and EU Pharmaceutical Companies, Establishment Registration Status, Bioresearch Health Monitoring Information System, 3PL Contract Wholesale Distributor and Third-Party Logistics Providers Reporting

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## Included Datasets

1. Bioresearch Monitoring Information System

The Bioresearch Monitoring Information System (BMIS) file contains information submitted to FDA (Food and Drug Administration) identifying clinical investigators, contract research organizations, and institutional review boards involved in the conduct of Investigational New Drug studies with human investigational drugs.

2. Directory of US and EU Pharmaceutical Companies

This dataset is a directory of the different pharmaceutical companies in the United States and the European Union. It includes the company’s specialization, physical address, contact details, email and website links.

3. Directory of US EU and Other Biotech Companies

This dataset is a directory of the different biotech and biopharmaceutical companies in the United States and the European Union. It includes the company’s specialization, physical address, contact details, email and website links.

4. Drug Establishment Annual Registration Status

The Drug Establishments Registration Site (DERS) is a database of information submitted by drug firms to register establishments (facilities) which manufacture, prepare, propagate, compound or process drugs that are commercially distributed in the U.S. or offered for import to the U.S Establishments must be registered within 5 days of beginning operations.

5. Drug Wholesale Distributor Third Party Logistics Providers Reporting

The Drug Wholesale Distributor and Third-Party Logistics Provider Reporting Database contain information submitted by wholesale distributors and third-party logistics providers (3PLs) regarding logistics and licensing.

6. FDA Acronyms and Abbreviations Database

Food and Drug Administration (FDA) conducts inspections of establishments that manufacture, process, pack, or hold FDA-regulated products, before approving products and/or after products are on the market, to determine the establishment’s compliance with the FDA laws. This document is called an FDA Form 483, which includes the name of the firm and the date(s) of inspection, and lists the observations made by the investigator during the inspection when there are objectionable conditions.

7. Required Clinical Trial After Approval Database

This dataset is the main file to construct the FDA (U.S. Food and Drug Administration) Postmarketing Requirements and Commitments searchable database. Postmarketing requirements refers to studies required to be conducted under statutes or regulations after product approval. Postmarketing commitments are not required studies that sponsors conduct. Official FDA's website has an available database to provide public detailed information on postmarketing requirements and commitments studies.

8. US Pharmacy Drugstore Location

This dataset provides a list of drugstores, pharmacies and licensed pharmacists names in the United States, as well as the territories of American Samoa, Guam, Puerto Rico, the Commonwealth of the Northern Mariana Islands, and the Virgin Islands, with detailed geolocation identifiers such as latitude and longitude of each drugstore or pharmacy, as well as telephone numbers, addresses, website URLs and other provider information.

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## 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

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#### 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.

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## Need Help?

* If you have questions about our products, contact us at <info@johnsnowlabs.com>.

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## About Us

[John Snow Labs](https://www.johnsnowlabs.com/), an AI and NLP for healthcare company, provides state-of-the-art software, models, and data to help healthcare and life science organizations build, deploy, and operate AI projects.