Drug Master Files for CBER-Regulated Products

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Providing Submissions in Electronic Format — Postmarketing Safety Reports for Vaccines

Draft Guidance for Industry This guidance document is for comment purposes only. The technical specification associated with this guidance is provided in a separate document and is updated periodically. To ensure that you have the most recent version of the technical specifications document, check the CBER ICSR Specifications Web page at: http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/ucm174963.htm Reference Information About…

Draft Guidance for Industry: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products

PDF (Printer version) This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food…

Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products

(PDF Version – 165KB) I. Introduction II. Background III. Preclinical Study Considerations A. Preclinical Program Objectives B. Recommendations for General Preclinical Program Design. 1. Investigational CGT Products Used in Preclinical Studies 2. Animal Species Selection 3. Selection of Animal Models of Disease/Injury 4. Proof-of-Concept (POC) Studies 5. Toxicology Studies 6. Product Delivery Considerations 7. Good Laboratory Practice (GLP)…

Summary Basis for Regulatory Action

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Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

PDF Version (PDF – 156KB) This guidance document is for comment purposes only. Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets…

Draft Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis)

  I. Introduction II. Background III. Recommendations IV. References Reference Information: About this guidance document To obtain copies of this document For questions regarding this document FDA office that authored this guidance October 2013 Return to Table of Contents Return to Table of Contents http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095440.htm. Return to Table of Contents FDA Guidance for Industry: Eligibility Determination for…