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  2. Design controls - Wikipedia

    en.wikipedia.org/wiki/Design_controls

    Design input, including intended use and user needs (also known as customer attributes) Design output, including evaluation of conformance to design input requirements through: Design verification confirming that the design output meets the design input requirements ("did we design the device right?")

  3. Electronic common technical document - Wikipedia

    en.wikipedia.org/wiki/Electronic_Common...

    However, additional specifications may be applied in national and continental contexts. In the United States, the Food and Drug Administration (FDA) layers additional specifications onto its requirements for eCTD submissions, including PDF, transmission, file format, and supportive file specifications.

  4. 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]

  5. Center for Biologics Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Biologics...

    Originally, CBER was part of what became the National Institutes of Health, rather than the FDA. [8] Its mission included a mandate to foster the development of new vaccines. [8] The Bureau was transferred from the NIH to the FDA in 1972, where it was renamed Bureau of Biologics and focused on vaccines, serums for allergy shots, and blood ...

  6. Common Technical Document - Wikipedia

    en.wikipedia.org/wiki/Common_Technical_Document

    Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]

  7. FDA reverses course, calls for vaccines for fall 2024 to ...

    www.aol.com/fda-reverses-course-calls-vaccines...

    The FDA is reversing course on its COVID vaccine guidance: Rather than having a vaccine that targets the older JN.1 variant, the FDA said fall 2024 vaccines should target a newer strain of the virus.

  8. Certificate of pharmaceutical product - Wikipedia

    en.wikipedia.org/wiki/Certificate_of...

    The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).

  9. Center for Drug Evaluation and Research - Wikipedia

    en.wikipedia.org/wiki/Center_for_Drug_Evaluation...

    FDA Building 51 is one of the main buildings in its White Oak campus that houses the Center for Drug Evaluation and Research. The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act.