Bar Code Requirements for Blood Banks

<!– –> <!– Page Last Updated: 06/10/2015 –> Page Last Updated: 06/10/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

U.S. Food and Drug Administration Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products (HCT/Ps)

Printable PDF (98 KB) U.S. Food and Drug AdministrationRegulation of Human Cells, Tissues, or Cellular or Tissue-Based Products(HCT/Ps) Laura M. St. Martin, M.D., M.P.H.Medical Officer, Division of Human TissuesRosemont, Illinois, August 29, 2007 Celia M. Witten, Ph.D., M.D.Director, Office of Cellular, Tissue, and Gene TherapyNew York, New York, September 6, 2007 Tissue Rules Brief History…

FDA Update

Printable PDF – 377KB Melissa Greenwald, M.D.Division of Human Tissues OCTGT, CBER, FDA AATB 31st Annual Meeting 18 September 2007 Boston, MA FDA Update Registration and Listing Exemptions and Alternatives Adverse Reaction (AR) Reporting HCT/P Deviations Publications Registration Registration Annual registration update required in December Electronically registered establishments were notified via email if not updated…

FDA Update: Relevant to Reproductive Establishments

Printable PDF – 510KB Martha A. Wells, MPH, RACDivision of Human TissuesOffice of Cellular, Tissue, and Gene TherapiesCenter for Biologics Evaluation and Research (CBER), [email protected] American Association of Tissue BanksAnnual Meeting September 17, 2007, Boston, MA Will Discuss FDA Requirements: History/Applicability Registration and Listing Donor Eligibility (DE) Requirements Current Good Tissue Practice (CGTPs) Testing Guidance…

October 11, 2007 Transcripts

Processing of Orthopedic, Cardiovascular and Skin Allografts THE FOOD AND DRUG ADMINISTRATIONCENTER FOR BIOLOGICS EVALUATION AND RESEARCHCENTER FOR DEVICES AND RADIOLOGICAL HEALTHTHE CENTERS FOR DISEASE CONTROL AND PREVENTION NIH Clinical CenterMasur AuditoriumBethesda, Maryland Printable Version (PDF, 441 KB) Thursday, October 11, 2007 IntroductionCelia Witten, Ph.D., M.D.Leslie Kux Session 1Ruth Solomon, M.D. (Moderator)Samuel Doppelt, M.D.Richard Jonas,…

October 12, 2007 Transcripts

Processing of Orthopedic, Cardiovascular and Skin Allografts THE FOOD AND DRUG ADMINISTRATIONCENTER FOR BIOLOGICS EVALUATION AND RESEARCHCENTER FOR DEVICES AND RADIOLOGICAL HEALTHTHE CENTERS FOR DISEASE CONTROL AND PREVENTION NIH Clinical CenterMasur AuditoriumBethesda, Maryland Printable Version (PDF, 287 KB) October 12, 2007 Session 3 Mary Marlarkey (Moderator)Steven Arnoczky, M.D.David FronkJoel OsborneJoyce Hansen P R O C…

July 22, 2004 Approval Letter

<!– –> <!– Page Last Updated: 06/10/2015 –> Page Last Updated: 06/10/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

CBER’s Sentinel Program

<!– –> <!– Page Last Updated: 04/23/2015 –> Page Last Updated: 04/23/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry

PDF Version (PDF – 100KB) Additional copies of this guidance are available from the Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD  20993-0002, or by calling 1-800-835-4709 or 240-402-7800, or email [email protected], or from the Internet at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. For questions on the content of this…