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Recently Posted Guidance Documents

U.S. Food and Drug Administration sent this bulletin at 01/11/2021 12:44 PM EST

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US Food and Drug Administration

Recently Posted Guidance Documents

  • 1/6/2021 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff
  • 1/6/2021 - Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff
  • 1/5/2021 - Mouse Embryo Assay for Assisted Reproduction Technology Devices
  • 1/5/2021 - Human Gene Therapy for Neurodegenerative Diseases: Draft Guidance for Industry
  • 1/4/2021 - IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators: Draft Guidance for Sponsor-Investigators

Guidance Document Search

  • Search all FDA official guidance documents and other regulatory guidance
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