Policy Updates

FDA, NIH Issue Guidance on Conducting Clinical Trials During a Pandemic

ASGCT Staff | April 06, 2020

Resources are available for researchers and patients looking for clinical trials information during the COVID-19 pandemic.

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ASGCT Applauds FDA's Gene Therapy Guidance Documents

Adora Ndu, PharmD, J.D. | February 03, 2020

Dr. Ndu is chair of the ASGCT Regulatory Affairs Committee and Vice President of Regulatory Affairs; Policy, Research, Engagement (PRE) & International at BioMarin Pharmaceutical Inc.

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ASGCT Invited to Join USP as a Voting Member

ASGCT Staff | January 08, 2020

ASGCT’s Regulatory Affairs Committee Chair, Adora Ndu, PharmD, J.D., (pictured below at the Policy Summit) will serve as the ASGCT delegate to the USP Convention for a five-year cycle.

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FDA photo

Margaret Hamburg, M.D. to Speak at Policy Summit

ASGCT Staff | September 26, 2019

Margaret Hamburg, M.D., an internationally recognized expert in medicine and public health, will be one of the keynote speakers on November 6, the third and final day of the ASGCT Policy Summit in Washington, D.C.

 

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Credit: Daniel Soñé Photography, LLC

NIH Director Collins to Speak at ASGCT Policy Summit

ASGCT Staff | September 05, 2019

Francis Collins, M.D., Ph.D., director of the National Institutes of Health, will deliver his keynote address, "The Need for an International Moratorium on Clinical Uses of Human Germline Gene Editing," on day three of the ASGCT Policy Summit, November 6.

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NIH Director Francis Collins, M.D., Ph.D
Credit: NIH

What to Expect at the ASGCT Policy Summit

ASGCT Staff | September 04, 2019

With a new name and expanded programming, the 2019 ASGCT Policy Summit brings a wide range of gene therapy experts and stakeholders from around the world to Washington, D.C. November 4-6 to discuss the challenges of and solutions to successful gene therapy development, access, and use.

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Credit: U.S. Mission Photo by Eric Bridiers, Flickr.com

ASGCT Submits Comments to WHO Advisory Committee

ASGCT Staff | August 22, 2019

ASGCT submitted comments on August 16 to the World Health Organization’s (WHO) Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing regarding guidance to governments, institutions, and researchers on scientific, ethical, social, and legal challenges related to both germline and somatic cell human genome editing.

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Scientific Leaders Call For Global Moratorium on Germline Gene Editing

April 24, 2019

In a letter sent to U.S. Department of Health and Human Services Secretary Alex Azar today, a broad collective of 62 individual scientists, bioethicists, and biotechnology executives, including past-presidents and current board of directors members from ASGCT, across industry and academia called for collaboration on a binding global moratorium on human clinical germline experimentation.

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ASGCT Advocacy Annual Plan 2019

ASGCT Staff | January 24, 2019

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.

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ASGCT Submits Comment on FDA Gene Therapy Guidance Documents

ASGCT Staff | December 11, 2018

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.

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Full Summary of ASGCT's FDA Liaison Meeting

ASGCT Staff | October 25, 2018

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.

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ASGCT Submits Comments to CMS on OPPS Proposal

ASGCT Staff | October 09, 2018

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.

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Image background: Rita Elena Serda, Duncan Comprehensive Cancer Center at Baylor College of Medicine, National Cancer Institute, National Institutes of Health

ASGCT Supports NIH/RAC Recommendation

ASGCT Staff | August 30, 2018

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.

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ASGCT Submits Comment on CAR T-Cell Therapy Coverage and Reimbursement

ASGCT Staff | July 26, 2018

ASGCT submitted comments last month to the Centers for Medicare & Medicaid Services (CMS) on Medicare coverage and reimbursement of CAR T-cell therapies as part of the Society’s effort to improve access to approved gene therapies.

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FDA infographic by Michael J. Ermarth

Six New FDA Guidance Documents Open for Comment

ASGCT Staff | July 19, 2018

With new FDA guidance drafts addressing hemophilia, retinal disorders, rare diseases, and manufacturing standards, ASGCT will be evaluating the specific content of the guidance documents leading up to the September 13 liaison meeting with the FDA. The Society will provide recommendations related to the details of these guidance documents.

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The Near Future of Gene Therapy Regulation

The Clinical Trials and Regulatory Affairs Committee | July 02, 2018

In a meeting with ASGCT organizational partner Research America, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER), discussed FDA guidance documents and elaborated on the agency’s interaction with their European counterparts in relation to gene and cell therapy.

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2020

ASGCT Policy Summit

September 23-25, 2020