This webinar will provide information about the ins and outs of the approval mechanisms through the FDA for those human tissue products that are regulated as biological drugs or medical devices. The presentation will be provided by individuals who have experienced the trials and tribulations of seeking FDA approval via IND/BLA or PMA/510(k) for these types of HCT/Ps.

This webinar will provide information about the ins and outs of the approval mechanisms through the FDA for those human tissue products that are regulated as biological drugs or medical devices. The presentation will be provided by individuals who have experienced the trials and tribulations of seeking FDA approval via IND/BLA or PMA/510(k) for these types of HCT/Ps.

The tissue banking industry is undergoing an “era of opportunity” as the need for supplying the medical field with a variety of regenerative medicine solutions increases. As the regulatory paradigm has evolved, so have days of tissue banks marketing products exclusively regulated as Section 361 Human Cells, Tissues, and Cellular and Tissue-Based Products. In a regulatory world where tissue may be regulated as a Section 361 HCT/P, as a Section 351 HCT/P, or even as a medical device, the requirements for reporting adverse outcomes have never been more confusing to new and existing players in this emerging regulatory space for industry. Join John Mayhall, the Mayor of Regulationville, and Kip Hanks, AATB Director of Regulatory and Governmental Affairs, as we navigate the many regulatory pathways and requirements for human tissue product adverse outcomes reporting.

The tissue banking industry is undergoing an “era of opportunity” as the need for supplying the medical field with a variety of regenerative medicine solutions increases. As the regulatory paradigm has evolved, so have days of tissue banks marketing products exclusively regulated as Section 361 Human Cells, Tissues, and Cellular and Tissue-Based Products. In a regulatory world where tissue may be regulated as a Section 361 HCT/P, as a Section 351 HCT/P, or even as a medical device, the requirements for reporting adverse outcomes have never been more confusing to new and existing players in this emerging regulatory space for industry. Join John Mayhall, the Mayor of Regulationville, and Kip Hanks, AATB Director of Regulatory and Governmental Affairs, as we navigate the many regulatory pathways and requirements for human tissue product adverse outcomes reporting.

This session will include a description of FDA’s most recent reorganization of its field offices, current hot regulatory topics, and the most commonly issued FDA 483 observations for HCT/P establishments.

This session will include a description of FDA’s most recent reorganization of its field offices, current hot regulatory topics, and the most commonly issued FDA 483 observations for HCT/P establishments.

AATB's Director of Regulatory and Governmental Affairs, Kip Hanks, will highlight and discuss the most common FDA 483 observations cited during inspections of accredited and non-accredited human tissue banks over the past few years.

AATB's Director of Regulatory and Governmental Affairs, Kip Hanks, will highlight and discuss the most common FDA 483 observations cited during inspections of accredited and non-accredited human tissue banks over the past few years.

AATB's Director of Regulatory and Governmental Affairs, Kip Hanks, will highlight and discuss the most common FDA 483 observations cited during inspections of accredited and non-accredited human tissue banks over the past few years.

AATB's Director of Regulatory and Governmental Affairs, Kip Hanks, will highlight and discuss the most common FDA 483 observations cited during inspections of accredited and non-accredited human tissue banks over the past few years.

In this presentation, we will review the process of an FDA audit from start to finish.

In this presentation, we will review the process of an FDA audit from start to finish.

Sharon O’Callaghan, FDA CBER Consumer Safety Officer, will present the regulatory requirements for reporting adverse reactions and HCT/P deviations to the FDA. Kip Hanks, AATB Director of Regulatory and Governmental Affairs, will present the Standards requirements for notifying AATB of reportable events. Questions will be submitted by attendees prior to the webinar.

In this presentation, Kip Hanks, Biologics National Expert for FDA's Office of Regulatory Affairs, Office of Biological Products Operations, will review current trends in FDA findings and processes.

Through this presentation, Kip Hanks, Biologics National Expert for FDA's Office of Regulatory Affairs, Office of Biological Products Operations, will review current trends in FDA findings and processes.