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Rules and Regulations
Online Resources
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Regulations.gov
Search all publicly available regulatory materials, e.g., trending regulations, public comments, supporting analyses, Federal Register (FR) notices, and rules. Submit comments, applications, or adjudication documents for regulations. Subscribe to receive email notifications about a specific regulation.
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How Drugs are Developed and Approved
Learn more about the development and approval process for drugs under the FDA, including finding links to different application types.
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Current Good Manufacturing Practice (CGMP) Regulations
Learn more about the FDA's CGMP regulations for drugs, which contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a drug product.
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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.
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Purple Book: Database of Licensed Biological Products
The Purple Book database contains information on all FDA-licensed (approved) biological products regulated by the Center for Drug Evaluation and Research (CDER), including licensed biosimilar and interchangeable products, and their reference products.
The Purple Book also contains information about all FDA-licensed allergenic, cellular and gene therapy, hematologic, and vaccine products regulated by the Center for Biologics Evaluation and Research (CBER).
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WHO Guidelines: Norms and Standards for Pharmaceuticals
This web page links to all current WHO norms and standards for pharmaceuticals guidelines which are grouped into (1) development, (2) production, (3) distribution, (4) inspection, (5) quality control, (6) regulatory standards and (7) specific texts for prequalification of medicines.
