USFDA

Recently Posted Guidance Documents

U.S. Food and Drug Administration sent this bulletin at 12/17/2021 09:20 AM EST

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US Food and Drug Administration

Recently Posted Guidance Documents

  • 12/16/2021 - Inspection of Injectable Products for Visible Particulates: Draft Guidance for Industry
  • 12/16/2021 - Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Draft Guidance for Industry and Food and Drug Administration Staff
  • 12/10/2021 - Q3C(R8) Impurities: Guidance for Residual Solvents Guidance for Industry: Guidance for Industry
  • 12/10/2021 - Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Developing New Products : Draft Guidance for Industry
  • 12/10/2021 - Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry : Draft Guidance for Industry
  • 12/10/2021 - Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID-19 Public Health Emergency: Guidance for Industry and Health Care Professionals

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  • Search all FDA official guidance documents and other regulatory guidance
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