USFDA

Recently Posted Guidance Documents

U.S. Food and Drug Administration sent this bulletin at 09/13/2024 03:37 PM EDT

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US Food and Drug Administration

Recently Posted Guidance Documents

  • 09/13/2024 - Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements
  • 09/13/2024 - Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
  • 09/12/2024 - Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)
  • 09/12/2024 - Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry
  • 09/11/2024 - ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry
  • 09/10/2024 - Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff
  • 09/06/2024 - Withdrawn Guidances (Biologics)

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  • Search all FDA official guidance documents and other regulatory guidance
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