Drug Safety Databases
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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 sub...
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This dataset, the VIS to Current URL data contains the URL links to both the Portable Document Format (PDF) version of the VIS as well as the HyperText Markup Language (HTML) versi...
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Why Purple? The “Purple Book” is an easy-to-remember nickname for the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchan...
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Why Purple? The “Purple Book” is an easy-to-remember nickname for the “Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchan...
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This dataset is created by Crowd Flower. Contributors at Crowd Flower read sentences in which both a chemical (like Aspirin) and a disease (or side-effect) were present. They then ...
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The Clinical Investigator Inspection List contains names, addresses, and other information gathered from inspections of clinical investigators who have performed studies with inves...
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FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and...
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Drugs, substances, and certain chemicals used to make drugs are classified into five (5) distinct categories or schedules depending upon the drug’s acceptable medical use and the...
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In many cases Vaccines Groups represent vaccines that vaccinate against a single disease. In a few cases they represent vaccines that vaccinate against more than one disease, but a...
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Validation procedures can be used by humans as check-lists to verify if their submission is correct. These are written specific and operational so that they may be checked by syste...