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- Long Term Follow-Up After Administration of Human Gene Therapy Products
In this guidance, we provide a brief introduction of the product characteristics, patient-related factors, and the preclinical and clinical data that should be considered when assessing the need
- Federal Register, Volume 85 Issue 20 (Thursday, January 30, 2020) - GovInfo
The guidance represents the current thinking of FDA on ``Long Term Follow-Up After Administration of Human Gene Therapy Products '' It does not establish any rights for any person and is not binding on FDA or the public You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations II
- Official Guidance FDA Long Term Follow-Up After Administration of Human . . .
The guidance document provides sponsors, who are developing a human gene therapy (GT) product, recommendations regarding the design of long term follow-up (LTFU) observational studies for the collection of data on delayed adverse events following administration of a GT product
- Long term follow-up after administration of human gene therapy products
Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020 Language (s): English Format: Text Subject (s): Genetic Therapy -- adverse effects Product Surveillance, Postmarketing Drug Evaluation, Preclinical United States United States Department of Health and Human Services United States Food and Drug
- Long Term Follow-Up After Administration of Human Gene Therapy Products . . .
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Long Term Follow-Up After Administration of Human Gene Therapy Products " The guidance document provides sponsors, who are developing a human gene therapy (GT) product, recommendations
- Long-Term Follow-Up in Gene Therapy Trials: Ensuring Patient Engagement . . .
In January 2020, the FDA released updated guidance on Long-term Follow-up After Administration of Human Gene Therapy Products This document includes recommendations regarding the design of LTFU studies for the collection of data on delayed adverse events and long-term safety and efficacy following gene therapy administration
- Long Term Follow-up After Administration of Human Gene Therapy Products . . .
Issued by: Food and Drug Administration (FDA) Issue Date: January 28, 2020 HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities We are in the process of retroactively making some documents accessible
- Understanding Long Term Follow-Up for Gene Therapy Clinical Trials
The FDA's Long-Term Follow-Up (LTFU) guidance introduces gene product characteristics, patient related factors, and the related preclinical and clinical data to be considered
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