No clinical trial information was provided in this BLA. Return to TOC Gender Male Female Unknown Table 16 describes the exposure of a subset of the safety population to DUCORD. *For multiple-unit recipients, the lowest level of HLA match was chosen. payday advance loans 8.3 Caveats Introduced by Pooling of Data Across Studies/Clinical Trials The dataset is pooled from all the voluntary reports of retrospective data. Please refer to Table 10 for the selection of the subset of the patients.

Age Mean (SD) Median Range Gender Male Female Unknown Immunological rejection is the primary cause of graft failure and may be fatal.

A subset of the safety population has available data for the analyses of GVHD. The treatment of choice to ameliorate the symptoms is systemic corticosteroids. No information regarding engraftment syndrome was submitted in this BLA. Serial monitoring of blood for EBV DNA may be warranted in high-risk groups. No reports of malignancies of donor origin were submitted to this BLA. No analyses of dose dependency for adverse events were conducted for this BLA. See 8.4 for analyses of total death and death at day 100 post transplantation. There has been no experience with overdosage of HPC-C in human clinical trials. ? Infusion reactions were documented in 19% (72/388) of DUCORD infusions. The types of DUCORD infusion reactions are similar to the COBLT data.

? No reports of unexpected adverse reactions were submitted to the BLA. ? HPC, Cord Blood can provide a broader and prompt source of HSC. The review team recommended, and the applicant agreed, to do the following:

12.1 Donna Przepiorka. Safety Review Dockets and Public Information. 2011 12.2 John Hyde. Clinical Efficacy Review Nonmalignant Indications. 2011 12.3 Maura O'Leary. Clinical Efficacy Review for Hematological Malignancies. This recall does NOT include any Turkey Hill products including peanut butter. Turkey Hill Moose Tracks Light Recipe Ice Cream is NOT included in the recall. This letter serves to notify healthcare professionals that Cephalon, Inc. Please note that this change pertains only to the product name of GABITRIL.

The formulation and manufacturing process of GABITRIL Tablets has not changed. All products manufactured before January 30, 2009 are affected by this recall.

FOR IMMEDIATE RELEASE -- April 16, 2009 -- Alternative Baking Company, Inc. Novo Nordisk Inc. Attention: Cindy Cao, PhD December 7, 2012 Sent by email For more information, please visit www.bi-lo.com and www.winn-dixie.com . CBER completed its key project on Fecal Microbiome Transplantation Workshop. FDA conveyed the Late-Cycle Meeting package to Biogen on August 28, 2013. Additional discussion: Biogen concurred with the Agency's request. There are insufficient data to support manufacturing on ------(b)(4)--------. [1 - Jain A.K., Murty M.N. and Flynn P.J. (1999). Data Clustering: A review. For a copy of the guidance, visit: http://www.fda.gov/cber/gdlns/cordbld.pdf The facility is currently dedicated to the manufacture of JEV Vaccine.

Entry to -(b)(4)- and -(b)(4)- changing areas are from the -----(b)(4)-----. Materials and equipment enter the clean rooms via the JEV lobby/transfer area.

In-process sampling of the viral solution takes place on Days ----(b)(4)----. However, no protocols or results from the cleaning validation were provided.

(see Questions for Applicant section, Filing letter questions, Number 4). -(b)(4)- employs the following methods/assays to ensure product quality; Three of these batches were compared against the consistency lots, above. Material for this batch was used in the pivotal non-inferiority trial IC51-301. Media fill lots were ----------(b)(4)-----------------------------------. All operators are involved in ----(b)(4)--- PST in any 12-month period. The syringe contains a ---------(b)(4)---------- elastomer plunger/stopper.

The firm's response is reviewed in the 483 response review memorandum. Samples, aseptically removed from the -(b)(4)- , confirmed this result.

It is supplied by -(b)(4)- air compressors operating on a duty/standby set-up. Compressed air is routinely tested to assure physical and microbial quality. Intercell responded to the July 24, 2008 questions on August 11, 2008. On September 5, 2008 Intercell provided -(b)(4)- response, as follows: Administrative practice and procedure, Food additive petitions, Food additives. 1785-1788 as amended, 74 Stat. 399-407 as amended, 82 Stat. 343-351, 90 Stat. * * * * * b. In 312.20 by revising paragraph (c), to read as follows: 314.50 Content and format of an application. 314.55 Abbreviated application. 314.71 Procedures for submission of a supplement to an approved application. 314.100 Time frames for reviewing applications. 314.101 Filing and application.

314.102 Communications between FDA and applicants. 314.103 Dispute resolution. 314.104 Drugs with potential for abuse. 314.105 Approval of an application. 314.300 Procedure for the issuance, amendment, or repeal of regulations. 540-560 (21 U.S.C. 351, 352, 353, 355, 356, 357, 360b-360f, 371, 376); sec. Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. Two copies of the application are required, an archival copy and a review copy.