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  2. Title 21 of the Code of Federal Regulations - Wikipedia

    en.wikipedia.org/wiki/Title_21_of_the_Code_of...

    Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration

  3. Medication package insert - Wikipedia

    en.wikipedia.org/wiki/Medication_package_insert

    In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.

  4. List of Guidances for Statistics in Regulatory Affairs

    en.wikipedia.org/wiki/List_of_Guidances_for...

    FDA: Clinical trial endpoints for the approval of cancer drugs and biologics [17] provides recommendations to applicants on endpoints for cancer clinical trials submitted to the Food and Drug Administration (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications.

  5. Food and Drug Administration - Wikipedia

    en.wikipedia.org/wiki/Food_and_Drug_Administration

    The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...

  6. Good documentation practice - Wikipedia

    en.wikipedia.org/wiki/Good_documentation_practice

    Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.

  7. FDA sets limits on lead in some baby foods - AOL

    www.aol.com/fda-sets-limits-lead-baby-210654868.html

    The U.S. Food and Drug Administration is for the first time setting guidelines for levels of lead in processed baby foods such as jarred fruits and vegetables. Part of an effort to reduce exposure ...

  8. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    The CTD is maintained by the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). [1] [2] After the United States, European Union and Japan, the CTD was adopted by several other countries including Canada [3] and Switzerland. [1]

  9. Good manufacturing practice - Wikipedia

    en.wikipedia.org/wiki/Good_manufacturing_practice

    Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, [1] cosmetics, [2] pharmaceutical products, [3] dietary supplements, [4] and medical devices. [5]

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