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  1. fda.gov
    https://www.fda.gov › about-fda › plain-writing-its-law › plain-writing-work

    Plain Writing at Work | FDA

    Nov 15, 2024 · Plain Writing ExamplesAt FDA, we are working to create letters, reports, Web pages, and other public documents using plain language principles to ensure plain, clear …

  2. fda.gov
    https://www.fda.gov › about-fda › plain-writing-its-law

    Plain Writing: It's the Law! | FDA

    Nov 15, 2024 · Discover how FDA is implementing the Plain Writing Act and Plain Language Principles in our communications with you.

  3. fda.gov
    https://www.fda.gov › about-fda › center-drug...

    OPDP Frequently Asked Questions (FAQs) | FDA

    As mentioned above, in the case of print advertisements, FDA encourages sponsors to write their product brief summaries in consumer-friendly language and to follow other guidance, as …

  4. fda.gov
    https://www.fda.gov › media › download
    [PDF]

    Guidance for Industry; Small Entity Compliance Guide; Direct …

    This means that firms must use consumer-friendly language and terminology that is readily understandable, rather than medical or technical jargon or terms usually more familiar to …

  5. fda.gov
    https://www.fda.gov › regulatory-information › search...

    Brief Summary and Adequate Directions for Use: Disclosing Risk ...

    The Food and Drug Administration (FDA) is announcing the reissuance of a revised draft guidance for industry (Revision 2) entitled “Brief Summary and Adequate Directions for Use: …

  6. fda.gov
    https://www.fda.gov › regulatory-information › search...

    Informed Consent | FDA

    This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations ...

  7. fda.gov
    https://www.fda.gov › about-fda › oncology-center...

    Patient-Friendly Language for Cancer Clinical Trials | FDA

    The FDA Oncology Center of Excellence Patient-Friendly Language Project began with the need to update the definitions of common terms used in cancer clinical trials for better …

  8. fda.gov
    https://www.fda.gov › media › download
    [PDF]

    Guidance for Industry - U.S. Food and Drug Administration

    Include a thorough major statement conveying all of the product’s most important risk information in consumer-friendly language.

  9. fda.gov
    https://www.fda.gov › ...

    Electronic Submission Template for Medical Device 510(k) …

    Oct 2, 2023 · This guidance provides further standards for electronic 510(k) submission, a timetable for establishment of the standards, and criteria for waivers/exemptions.

  10. fda.gov
    https://www.fda.gov › patients › learn-about-your-medicines

    Learn About Your Medicines | FDA

    Learn how to safely take your medicines.You will need to access DailyMed. The search allows you to search by any of the following: drug name, NDC code, manufacturer name, drug class …