Regulatory Affairs Information

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)

Report of Gene Therapy Stakeholders' Meeting (PDF) (April 7-5, 2005)

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

Long-Term Follow-up Meeting Summary from Molecular Therapy (PDF file)

New NIH Resource on Informed Consent (March 2004)

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ASGT Response to NIH Draft Guidance on Informed Consent (April 30, 2003)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

Regulatory Affairs Professional Society (RAPS)

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