News Archives for Policy Updates

Recent News

ASGCT Advocacy Annual Plan 2019
January 24, 2019
Advocacy Policy Updates

Emboldened by our success last year, ASGCT is doubling down on our advocacy efforts and plans to establish the Society and its membership as a leading voice for policy decisions by increasing our presence in Washington, D.C.

ASGCT Submits Comment on FDA Gene Therapy Guidance Documents
December 11, 2018
Advocacy Policy Updates

ASGCT submitted comments to the FDA regarding six draft guidance documents on gene therapy development on Dec. 10. ASGCT welcomes the provisional guidance in the development of gene therapies and submitted 71 individual recommendations and requests for clarification for FDA consideration.

Full Summary of ASGCT's FDA Liaison Meeting
October 25, 2018
Advocacy Policy Updates

The September 13 liaison meeting between the FDA and ASGCT covered manufacturing, safety, and testing requirements for gene therapies, as well as an FDA update on the new RMAT designation. This deep-dive longread includes the recommendations from those discussions.

ASGCT Submits Comments to CMS on OPPS Proposal
October 09, 2018
Advocacy Policy Updates

ASGCT indicated its support for removal of patient care services from the CAR T-cell therapy Q codes for tisangenlecleucel and axicabtagene ciloleucel to more accurately report, and to obtain more sufficient reimbursement for, administration of these therapies.

ASGCT Supports NIH/RAC Recommendation

While the RAC serves a valuable role as an essential public forum for science, safety, and ethics, the current requirements for gene therapies have proven redundant.

22nd Annual Meeting
April 29 – May 2 | Washington D.C.