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[14 - Formal Meetings with Sponsors and Applicants for PDUFA Products Guidance Other review activities for which timelines will need to be determined: To: Pauline Cottrell, HFM - 380 & File of STN 125251/0 Acting Lab Chief, Laboratory of Hemostasis/Division of Hematology/OBRR Sunny Millet Bread – Deleted: “Antioxidants help prevent….” Health Max Bread – Deleted: “Antioxidants help prevent….”

Emmanuel Hanon, Ph.D. Vice President Global Vaccine Development GlaxoSmithKline These products were packaged at the Upsher-Smith plant in Plymouth, Minnesota. use of cialis pills This recall is being conducted with the knowledge and guidance of the FDA. Food and Drug Administration Room 1066 5630 Fishers Lane Rockville, MD Health Consequence Scoring for Biological Contaminants in Animal Feed NADH and NADPH-dependent reduction of coenzyme Q at the plasma membrane. Antioxidants & Redox Signaling 2 (2): 251-262. Published Material Baggio, E.; Gandini, R.; Plancher, A.C.; Passeri, M.; Carmosino, G. 1994. Budavari, S.; O’Neil, M.J.; Smith, A.; Heckelman, P.E.; Kinneary, J.F. Twelfth Edition. Merck & Co., Inc., New Jersey, p. 1679. Published Material

Chiba, T.; Sugiyama, K.; Kume, Y.; Shiojiri, H.; Watanabe, T.; Ozeki, M, 1972b. Toxicological studies of ubiquinone-IO (II) Subacute toxicity test in rabbits. J Chromatogr 425: 87. Cited In: Kontush et al., 1997. Published Material Clin Invest 71: S60. Cited In: Kontush et al., 1997. Published Material J Cardiac Failure 1: 101-107. Cited In: Tran et al., 2001. Published Material 2002. Prevention of mitochondrial oxidative damage using targeted antioxidants. Lagendijk, J.; Ubbink, J.B.; Delport, R.; Vermaak, W.J.H.; Human, J.A.

Research Communications in Molecular Pathology and Pharmacology 95 (1): 11-20. Lenaz, G. 2001. A critical appraisal of the mitochondrial coenzyme Q pool. Miles, M.V.; Horn, P.S.; Morrison, J.A:; Tang, P.H.; DeGrauw, T.; Pesce, A.J.

Mugford, CA.; and Kedderis, G.L. 1998. Sex-dependent metabolism of xenobiotics. Pepping, J. 1999. Coenzyme Q10. Am J Health Syst Pharm 56 (6): 519-521. Runquist, M.; Parmtyd, I.; Thelin, A.; Chojnacki, T.; Daliner, G. 1995. Distribution of branch point prenyltransferases in regions of bovine brain. J Neurochem 65: 2299-2306. Cited In: Turunen et al., 2004. Published Material Schultz, J.R.; Ellerby, L.M.; Gralla, E.B.; Valentine, J.S.; Clarke, C.F. 1996. Autoxidation of ubiquinol-6 is independent of superoxide dismutase. Biochemistry 35: 6595. Cited In: Villalba et al., 2000. Published Material The Parkinson Study Group. Arch Neural 59 (10): 1541-1550. Abstract only. Arterioscler Thromb Vast Biol 16: 687-696. Cited In: Thomas et al., 1999.

Extramitochondrial functions of coenzyme Q, In: Kagan, V-E. and.Quinn, P.J. Weber, C.; Jakobsen, T.S.; Mortensen, S.A.; Paulsen, G.; Holmer, G. 1994.

Wittenstein, B.; Klein, E.M.; Finckh, B.; Ullrich, K.; Kohlschutter, A. 2002. Free Radical Biology & Medicine 33 (1): 103-110. Published Material No. A mammographic modality means a technology for radiography of the breast. The test is performed using DNA that is extracted from a patient's blood. Regulatory The Hib-MenCY-TT vaccine is not currently licensed in any country. Administration of the vaccine series may be initiated as early as age 6 weeks. Healthy infants 6-12 weeks (2, 4, 6 months) Healthy children 3-5 years (1 dose)

Hib-MenCY-TT-007 Australia Pivotal study Immunogenicity, Safety/Reactogenicity SB = single blinded; DB =double-blinded; R = randomized; C = controlled

Hib-MenCY-TT-006 US / Pivotal study Immunogenicity Safety and reactogenicity Group Hib-MenCY: Hib-MenCY-TT after priming with Hib-MenCY-TT + Pediarix Secondary objective: SAEs, NOCD*, rash (e.g. hives, ITP, petechiae), ER visits

4th dose of Prevnar , M-M-R II, Varivax, hepatitis A and influenza vaccine Group ActHIB + Pediarix Prevnar, influenza vaccine, rotavirus vaccine Table 4: Demographic characteristics of Hib-MenCY and Hib vaccine groups Pooled fourth dose phase studies Hib-MenCY-TT-004, -006, -008, -010, and -012** Pooled primary vaccination studies Hib-MenCY-TT-001, -005, -007, and -009* Pooled fourth dose vaccination studies Hib-MenCY-TT-006, -008, and -010** STN 1253633/0, Section 2.7.4, pages 146, 177, 199; Tables 61, 62 and 64 No consistent trend or statistical imbalance was reported in these studies.

Appendix B - Matrix of Rationale for Each of the Editorial Suggestions These values were not included due to the lack of methodological information. Contact: Consumer: (800) 874-8734 Media: Michael Valentine, CFO (847) 214-4509

ITEM #: 4009 PEANUT BUTTER SNACK PACK - WEIGHT: 8.5oz. There are no reported illnesses associated with these peanut butter cookies. This recall does not impact any other fish or seafood sold by Northcoast. The facility may wish to post a sign to explain how to file complaints. Experience With Monitoring of Bacterial Contamination of Platets ( PDF ) Hepatitis B Virus Nucleic Acid Testing (NAT) for Donors of Whole Blood ( PDF ) Current Trends in Plasma Product Manufacturing (Informational) ( PDF ) (ii) If more than one claim is the same for each drug component. i.e., c) (i) If one of the claims overlaps while a second claim does not, i.e., Attachment 3C - Maintanence fee statement for U.S. Patent No. 6,017,927

This condition is found in some finfish, notably barracuda and amber-jack. Ciguatera is one of many toxins that fish and shellfish can transmit. On a hot day (90 F or higher), food should not sit out for more than 1 hour. The POS could be a restaurant, grocery store, caterer, or your table at home. Department of Agriculture (whichever agency has jurisdiction over the food). The agency uses traceback techniques to determine the source of the food. Symptoms: Fever, stomach pains, headache, loss of appetite, and weakness. Exhibit 2–3. Status of the Pilot 1, Pilot 2 and Comparison Cohort Products Laboratory leader: Joshua Pfefer 301.796.2494 joshua.pfefer@fda.hhs.gov FOR IMMEDIATE RELEASE - September 13, 2013 - HeartSine Technologies, Ltd.

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