Recent Advisory Actions (Untitled Letters and Warning Letters) issued by FDA CBER include references to internet content (company websites, LinkedIn, Facebook, etc.) as part of how FDA determines the regulatory status of HCT/Ps. For an HCT/P to be regulated solely under the Public Health Service Act Section 361 and 21 CFR 1271, i.e., a “361 HCT/P,” it must be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.”

 

AATB is executing a Member Donor Recovery Survey to collect high-level data on the recovery of donated tissue by AATB-accredited tissue establishments. The survey was sent through Survey Monkey to all MwERs of AATB-accredited establishments in the U.S. and Canada that participate in donor recovery/acquisition focused on transplant-intended donations. The survey deadline is Friday, March 31. If you have questions or problems accessing the survey, please email davisa@aatb.org.

Regulatory Focus
Step four of the International Council for Harmonisation's (ICH) process has begun for the ICH S12 guideline on nonclinical biodistribution (BD) considerations for gene therapy products. The guideline is ready for regulators to adopt.

Medical News Today
Heart tissue cannot regenerate, so even if someone survives a heart attack, damage to heart tissue could cause problems or death over the years following the event. Researchers have found a way to treat heart tissue in mice before a heart attack which continues to protect them even months later.

Photonics
A technique used to provide clear images of planets can be used in biomedicine by providing focused images of tissue to help detect cancer below the skin.

ScienceDaily
A cell sheet applied directly to the surface can aid in healing wounds and encouraging regeneration of skin tissue.

Oncology Times
The microbiomes of patients with soft tissue sarcoma had multiple kinds of viruses that attract immune natural killer (NK) cells reducing metastasis and improving survival.

Join us September 17-20 at the Gaylord National Resort & Convention Center in National Harbor, Maryland, for the 2023 AATB Annual Meeting. Registration opens in June.

AATB's call for session proposals is an opportunity for AATB members to contribute their ideas for topics and speakers to the 2023 AATB Annual Meeting. The deadline for proposals is Friday, May 5, 2023. Submit your idea today!

The 2023 AATB Annual Meeting in National Harbor, MD, will provide an opportunity for members to showcase their work in support of tissue banking across all disciplines. AATB is seeking submissions in both the scientific and administrative categories. The deadline for submissions is Friday, May 26, 2023. Submit your abstract today!

Corinne Bell, Executive Director, Chief Operations Officer, and Treasurer of the Anatomy Gifts Registry, joins AATB on March 29 for a webinar detailing the relationships between NADOs and Tissue Banks, including referring cases to one another in case of deferral or sharing cases and where the organizations differ in terms of criteria for exclusion, inclusion, and deferrals.

What is inclusive leadership, and what does that even mean for a Tissue Bank? Joshua Brennan, Director of Tissue Operations for New England Donor Services, joins AATB on April 12 to explore the characteristics and principles of an inclusive leader. This webinar is geared toward OPO leaders, supervisors, trainers, and performance coaches and focuses on strategies, concepts, and case studies.

Alachua, Florida: The Donor Information Supervisor leads the team with excellence, effective communication, steady leadership, and a good attitude. Supervise the day-to-day activities of Donor Information Associates and act as department lead in the absence of other leadership Actively support staff success by facilitating one-on-one meetings, providing data driven feedback, identifying opportunities for growth and continuous coaching.

Bellevue, Washington: The Tissue Recovery Coordinator IV (TRC IV) works closely with the Tissue Resource Manager (TRM) and Director of Tissue Donation Services (TDS) to continually increase tissue donation and maintain acceptable rates of tissues recovered per donor.

Falls Church, Virginia: Under the general direction of the Regional Supervisor, Tissue Recovery, and in accordance with protocols, policies, and procedures established by the organization, AATB, FDA, processor SOP's, and other federal, state, and local regulations and/or guidelines, the Surgical Specialist 1 will perform a variety of duties associated with the surgical recovery of specific tissues, which include corneas, split thickness, and full thickness skin for transplantation and/or research purposes.