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March 24, 2011 Approval Letter
Our STN: BL 125123/734 Merck Sharp Dohme Corp.Attention: Alison Fisher, Ph.D.P.O. Box 1000UG2D-68North Wales, PA 19454-1099 Dear Dr. Fisher: We have approved your request to supplement your biologics license application (BLA) for Zoster Vaccine Live (ZOSTAVAX®), to include safety and efficacy data to support a label change for the use of ZOSTAVAX in individuals 50 to 59…
SOPP 8406: Managing PDUFA User Fee Payments and Billing Activities
Version #4 Effective Date: Date: October 19, 2009 1. Purpose This document describes the procedures used to determine the accuracy of information submitted by an applicant and to verify user fee payments relative to the Prescription Drug User Fee Act (PDUFA) of 1992, as reauthorized by the Food and Drug Administration Amendments Act of 2007. …
January 13, 2011 Approval Letter
Our STN: BL 125259/112 GlaxoSmithKline BiologicalsAttention: Matthew Whitman2301 Renaissance BoulevardP.O. Box 61540King of Prussia, PA 19406-2772 Dear Mr. Whitman: We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, to include a Patient Package Insert to the full prescribing information. In addition, please submit…
Cord Blood Banking – Information for Consumers
December 7, 2010 Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby’s cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood?…
Cord Blood Banking – Information for Consumers, December 7, 2010
Expecting a baby can be a very exciting time for soon-to-be-parents. It can also be very confusing, with many decisions to make. One choice prospective parents often face is whether to donate, bank or discard their baby’s cord blood. Did you know that the Food and Drug Administration (FDA) regulates cord blood? Here is some…
November 4, 2010 Approval Letter
Our STN: BLS 125300.150        Novartis Vaccines and Diagnostics, Inc.Attention: Christopher Webster, Ph.D.350 Massachusetts AvenueCambridge, MA 02139-4182  Dear Dr. Webster: We have approved your request to supplement your biologics license application for Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, to include revisions to the directions for product reconstitution in…
Complete List of Substantially Equivalent 510(k) Device Applications
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7345.848
Download PDF Version of Report  Back to Compliance Programs Main Page [email protected], or by mail to: Division of Inspections Surveillance, HFM-650Office of Compliance and Biologics QualityCenter for Biologics Evaluation and ResearchFood and Drug Administration1401 Rockville Pike, Suite 200NRockville, MD 20852-1448 Domestic Post-Market Inspections: Inspections classified NAI and VAI: Notify CBER, Office of Compliance and…
August 30, 2010 Clarification Letter
Our STN: BL 125254/132 CSL LimitedAttention: Paul Hartmann, R.Ph.1020 First AvenueP.O. Box 61501 King of Prussia, PA 19406-0901 Dear Mr. Hartmann: The purpose of this letter is to clarify your pediatric study fulfillment requirements that were omitted from our approval letter, dated November 10, 2009. Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c),…