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Regulatory Affairs Information

Funding for Biomedical Research

The American Society of Gene & Cell Therapy is seeking assistance from the gene and cell therapy community by contacting congressional representatives regarding the importance of funding for biomedical research.

You may download the letter template to send to your representatives here.

To find your State Representative please click here

NIH Outreach

Below are the follow up letters drafted to each Institute, Center with which the ASGCT leadership met in February 2013.

Center for Scientific Review

National Cancer Institute

National Center for Advancing Translational Sciences

National Eye Institute

National Human Genome Research Institute

National Heart, Lung and Blood Institute

National Institute on Aging

National Institute of Allergy and Infectious Diseases

National Institute of Arthritis and Musculoskeletal and Skin Diseases

National Institute of Child Health and Human Development

National Institute on Drug Abuse

National Institute of Dental and Cranofacial Research

National Institute of Diabetes and Digestive and Kidney Diseases

National Institute of General Medical Sciences

National Institute of Neurological Disorders and Stroke

Office of Biotechnology Activities

Office of the Director

Guidance for Industry: Gene Therapy Clinical Trials - Observing Subjects for Delayed Adverse Events (November 28, 2006)

Guidance for Industry: Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and uring Follow-up of Patients in Clinical Trials Using Retroviral Vectors (November 28, 2006)

Changes to Adverse Event Reporting -- eSubmissions, PSURs, ICRs (August 25, 2005)

ASGCT Clinical and Regulatory Affairs Committee

ASGT Response to FDA Critical Path Statement (July 2004)

Report from the ASGT Ad Hoc Committee on Retroviral-mediated Gene Transfer to Hematopoietic Stem Cells (April 2003)

ASGT Response to NIH Draft Guidance on Informed Consent (April 30, 2003)

The Sponsor’s Guide to Regulatory Submissions For an Investigational New Drug (PDF)
A practical guide for bench Scientists entering the clinical and regulatory realm

The International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use