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  1. www.fda.gov › inspections-compliance-enforcement-andIssuance of Untitled Letters | FDA

    2021年6月21日 · Posting. FDA generally posts an Untitled Letter to a Center website on FDA.gov when the Center has determined posting would fulfill one or more of the following objectives: (1) respond to 3 or ...

  2. www.fda.gov › inspections-compliance-enforcement-andWarning Letters | FDA - U.S. Food and Drug Administration

    Matters described in FDA warning letters may have been subject to subsequent interaction between FDA and the letter recipient that may have changed the regulatory status of issues discussed in the ...

  3. www.fda.gov › inspections-compliance-enforcement-andAbout Warning and Close-Out Letters | FDA

    • General FDA Warning Letters
    • Tobacco Retail Warning Letters
    • Drug Marketing and Advertising Warning Letters
    • Warning Letter Close-Out Letter Program

    When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also ...

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    Compliance check inspections of tobacco retailers occur periodically, and are conducted to determine a retail establishment’s compliance with the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and its regulations in effect, such as the Regulations Restricting the Sale ...

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    These letters, sorted by month, only cover Division of Drug Marketing and Communications and Drug Warning Letters. Some of the letters have been redacted or edited to remove confidential information. "Cyber" letters are sent electronically via the Internet to web sites that offer to sell online prescription drugs that may be illegal. The letters wa...

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    FDA may issue a Warning Letter close-out letter ("close-out letter") once the Agency has completed an evaluation of corrective actions undertaken by a firm in response to a Warning Letter. A close-out letter may issue when, based on FDA’s evaluation, the firm has taken corrective action to address the violations contained in the Warning Letter. Thi...

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  4. www.fda.gov › regulatory-information › search-fda-guidanceANDA Submissions -- Refuse-to-Receive Standards Rev.2 | FDA

    2020年4月21日 · You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and ...

  5. www.fda.gov › regulatory-information › search-fda-guidanceFormal Meetings Between the FDA and Sponsors or Applicants ...

    For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester (s)) following the procedures provided in ...

  6. www.fda.gov › regulatory-information › search-fda-guidanceInstitutional Review Boards Frequently Asked Questions | FDA

    2019年4月18日 · Learn about the role and responsibilities of IRBs in clinical research from FDA guidance and FAQs.

  7. www.fda.gov › about-fda › center-drug-evaluation-and-researchInstitutional Review Boards (IRBs) and Protection of Human ...

    FDA Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators. Institutional Review Board Questions: Contact the Office of Good Clinical Practice, 301-796-8340, or gcpquestions ...