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Recently Posted Guidance Documents

U.S. Food and Drug Administration sent this bulletin at 10/30/2020 10:02 AM EDT

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US Food and Drug Administration

Recently Posted Guidance Documents

  • 10/29/2020 - Providing Regulatory Submissions in Electronic Format -- Standardized Study Data
  • 10/28/2020 - Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry
  • 10/28/2020 - Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised): Guidance for Industry and Food and Drug Administration Staff
  • 10/28/2020 - Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date: Guidance for Industry, Stakeholders, Health Care Professionals, and Food and Drug Administration Staff
  • 10/27/2020 - Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
  • 10/27/2020 - Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies

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  • Search all FDA official guidance documents and other regulatory guidance
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