The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the United States Federal Government. CFR 21 Parts 300-499 include rules, regulations, and procedures about new drugs, investigational new drug application, diagnostic radiopharmaceuticals, over-the-counter drug products intended for oral ingestion that contain alcohol, and more.
Audience: Physicians, pharmacists, medical practitioners, drug and pharmaceutical manufacturers, and the general public may be interested in this regulatory volume. Other related products: Drug Master File (Red Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00404-1
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Investigational New Drug Application, (Green Paper Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00402-4
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New Drug Application: Biologic Licensing Application, Archival Copy (Blue Polyethylene Folder) can be found here: https: //bookstore.gpo.gov/products/sku/017-012-00392-3
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