Regulatory Issues Archive

Notice of NIH Guidelines Compliance and Recent Changes

ASGT Response to Proposed Rules related to 21 CFR Part 56: May 24, 2002

ASGT Response to NIH Guidelines for Research Involving Recombinant DNA Molecules

NIH Proposed Changes To Guidelines and Response From ASGT

The American Society of Gene Therapy, under the leadership of Ken Cornetta, Chair of the Clinical and Regulatory Affairs Committee, and Inder Verma, President of ASGT at that time, had crafted a response to the NIH guidelines of December 12, 2000 (federal register 65, no 239 ). The ASGT Board, Clinical and Regulatory Affairs Committee and others had input on the final version which was sent to the NIH/OBA as our official response. We have very carefully and with great circumspection formulated ASGT's response to the NIH. Below you will find the links to both documents.

ASGT Response to FDA Proposed Rule: April 16, 2001