FDA Public Workshop: Scientific Evidence in Development of HCT/Ps Subject to Premarket Approval
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9/8/2016
When: Thursday, September 8, 2016

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FDA Public Workshop; Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval

September 8, 2016
8:30am to 5:00pm

The Food and Drug Administration is announcing a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.”

Purpose and Scope of the Meeting
The purpose of the public workshop is to identify and discuss scientific considerations and challenges to help inform the development of human cells, tissues, and cellular and tissue-based products (HCT/Ps) subject to premarket approval, including stem cell-based products.

Location
The public workshop will be held at the following location:

FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, Great Room
Silver Spring, MD  20993-0002

Entrance for public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed.  For parking and security information, please refer to http://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm. 

Registration
Persons (including FDA employees) seeking to view the public workshop via Adobe Connect or who wish to attend in person must register at http://www.eventbrite.com/o/food-amp-drug-administration-fda-6730245227 on or before August 1, 2016.

There is no registration fee for this public workshop.  Early registration is recommended because seating is limited and is on a first-come, first-served basis.  There will be no onsite registration.

Contact Information
Tasha Johnson or Pauline Cottrell
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD  20990
240-402-8010
E-mail:  CBERPublicEvents@fda.hhs.gov (Subject line:  FDA SEDHC workshop)

http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm492499.htm

 

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