Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
March 1, 2015
May 16, 2019
7e121572-9573-4422-ac9b-6975e1e6dab6
Related Documents
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products: Guidance for Industry
Guidance DocumentJune 27, 2015Center for Biologics Evaluation and Research
Recommendations for Microbial Vectors Used for Gene Therapy: Guidance for Industry
Guidance DocumentSeptember 16, 2016Center for Biologics Evaluation and Research
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products: Guidance for Industry
Guidance DocumentAugust 27, 2015Center for Biologics Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox