Regulatory & Governmental Affairs

On Monday, May 20, 2024, the FDA announced the release of “Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Communicable Disease Agent or Disease” (RCDAD).

This testimony addresses critical legislative proposals to support patients with rare diseases, including H.R. 6705, the Effective Screening and Testing for Tuberculosis Act, and H.R. 7188, the Shandra Eisenga Human Cell and Tissue Product Safety Act.

On January 5, CDC published the article titled “Second Nationwide Tuberculosis Outbreak Caused by Bone Allografts Containing Live Cells – United States, 2023” in Morbidity and Mortality Weekly Report.

The three skin substitute LCDs/LCAs, entitled "Skin Substitute Grafts/Cellular and/or Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers," and proposed by CGS Administrators, LLC, Novitas Solutions, Inc., and First Coast Service Options, Inc. will not go into effect on October 1, 2023, as previously announced.

The effective date of 3 “skin substitute” Local Coverage Determinations (LCDs) issued by CGS Admi

AATB joined patient advocacy groups and medical associations in signing a letter sent to the CEOs of America’s largest commercial health insurers...

The 2023 Capitol Hill Fly-In was held in person on February 7 in Washington, DC, for the first time since 2019. The event included over 20 representatives from AATB who achieved more than 30 congressional meetings.

AATB submitted both oral and written comments for the CMS Skin Substitute Town Hall. 

The FDA released an official response to AATB's Citizen Petition.