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Dockets Management

Dockets Entered On August 21, 2007
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
2003D-0044 Reporting Results for Studies Evaluating Diagnostic Tests
2003P-0409 Reclassification for Moblie Bearing Knees from Class III and Class II
2004N-0226 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
2004N-0382 Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
2005D-0112 Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
2005N-0272 Irradiation in the Production, Processing & Handling of Food
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006F-0059 Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
2006N-0104 Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
2006N-0238 Debarment of Maria Anne Kirkman Campbell
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
2006P-0281 Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet
2006P-0379 To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl
2006P-0505 ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
2007D-0168 Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
2007D-0173 Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
2007N-0236 Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V
2007N-0264 Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
2007N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
2007P-0065 To increase print size of direct-to-consumer advertisements
2007V-0222 Projector for a Laser Light Show
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 20616 NBTY Vol #: 180
LET 20617 NBTY Vol #: 180
LET 20618 NBTY Vol #: 180
LET 20619 NBTY Vol #: 180
LET 20620 NBTY Vol #: 180
LET 20621 NBTY Vol #: 180
LET 20622 NBTY Vol #: 180
LET 20623 NBTY Vol #: 180
LET 20624 Enzmatic Vol #: 180
LET 20625 Enzmatic Vol #: 180
LET 20626 Enzmatic Vol #: 180
LET 20627 Enzmatic Vol #: 180
LET 20628 Enzmatic Vol #: 180
LET 20629 Enzmatic Vol #: 180
LET 20630 Enzmatic Vol #: 180
LET 20631 Enzmatic Vol #: 180
LET 20632 Enzmatic Vol #: 180
LET 20633 Josefino Gonzales Vol #: 180
LET 20634 Sciff Nutrition International Inc. Vol #: 180
LET 20635 Sciff Nutrition International Inc. Vol #: 180
LET 20636 Sciff Nutrition International Inc. Vol #: 180
LET 20637 Sciff Nutrition International Inc. Vol #: 180
LET 20638 Sciff Nutrition International Inc. Vol #: 180
LET 20639 Sciff Nutrition International Inc. Vol #: 180
LET 20640 Sciff Nutrition International Inc. Vol #: 180
LET 20641 Sciff Nutrition International Inc. Vol #: 180
LET 20642 Sciff Nutrition International Inc. Vol #: 180
LET 20643 Sciff Nutrition International Inc. Vol #: 180
LET 20644 Sciff Nutrition International Inc. Vol #: 180
LET 20645 Sciff Nutrition International Inc. Vol #: 180
LET 20646 The EFA Focus Company Vol #: 180
LET 20647 Bayer HealthCare Vol #: 180
LET 20648 Golden Temple Vol #: 180
LET 20649 HERB PHARM Vol #: 180
LET 20650 The Coromega Company, Inc. Vol #: 180
LET 20651 Applied Cognitive Sciences LLC Vol #: 180
LET 20652 NBTY Vol #: 180
LET 20653 NBTY Vol #: 180
LET 20654 NBTY Vol #: 180
LET 20655 NBTY Vol #: 180
LET 20656 NBTY Vol #: 180
LET 20657 NBTY Vol #: 180
LET 20658 NBTY Vol #: 180
LET 20659 NBTY Vol #: 180
LET 20660 NBTY Vol #: 180
LET 20661 MOLEAC Vol #: 180
1997S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)
LET 945 FDA/CSFAN to Wellness International Network, Ltd Vol #: 28
LET 946 FDA/CFSAN to Hansen Beverage Company Vol #: 28
LET 947 FDA/CFSAN to Microgravity Enterprises, Inc. Vol #: 28
LET 948 FDA/CFSAN to University Lab Technologies Vol #: 28
LET 949 FDA/CFSAN to Konsyl Phatmaceuticals, Inc. Vol #: 28
LET 950 FDA/CFSAN to Technical Marketing Manager Vol #: 28
LET 951 FDA/CFSAN to Herbal Extract Company of North America Vol #: 28
LET 952 FDA/CFSAN to Cardiac Wellness Supplements Vol #: 28
1998N-0359 Program priorities/Center for Food Safety & Applied Nutrition
EC 406 American Frozen Food Institute Vol #: 12
2003D-0044 Reporting Results for Studies Evaluating Diagnostic Tests
EC 7 Miracle 2 Soaps Vol #: 1
2003P-0409 Reclassification for Moblie Bearing Knees from Class III and Class II
LET 1 FDA/CDRH to Orthopedic Surgicla Manufacturers Association (OSMA) Vol #: 6
2004N-0226 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 010
EC 27 Mrs. Vonda Clerke Vol #: 1
EC 28 Mr. Luis Perez Vol #: 1
EC 29 Dr. Sara Stebbins Vol #: 1
2004N-0382 Food Labeling: Safe Handling Statements: Labeling of Shell Eggs
NFR 1 FDA Vol #: 1
2005D-0112 Guidance for Industry on Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
EC 44 Miss. karen kistler Vol #: 1
2005N-0272 Irradiation in the Production, Processing & Handling of Food
C 3746 David Peters Vol #: 61
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18335 G. McKillop Vol #: 198
2006F-0059 Safe Use of Polydextrose as a Bulking Agent, Formulation Aid, Humectant and Texturizer in All Foods, except Meat and Poultry (FAP 6A4763)
BKG 2 Background Material Vol #: 1
EA 2 Environmental Assessment Vol #: 1
FONS 1 Finding of No Significant Impact Vol #: 1
NFR 1 FDA Vol #: 1
2006N-0104 Agency Information Collection Activities: Proposed Collection; Comment Request; Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format
EC 7 Imgenex.corp Vol #: 1
2006N-0238 Debarment of Maria Anne Kirkman Campbell
LET 5 FDA to Maria Anne Kirkman Campbell, M.D. Vol #: 1
2006N-0454 Use of Ozone-Depleting Substances; Removal of Essential-Use Designations
C 1246 N. Rexford Vol #: 15
C 1247 K. Wells Vol #: 15
C 1248 P. Gandolfi Vol #: 15
C 1249 G. Sharpless Vol #: 15
C 1250 R. Compton Vol #: 15
C 1251 J. Meadows Vol #: 15
C 1252 S. Parker Vol #: 15
C 1253 J Kline Vol #: 15
C 1254 R. Jones Vol #: 15
C 1255 H. Frye Vol #: 15
C 1256 R. Gillespie Vol #: 15
C 1257 C Kuppenbender Vol #: 15
C 1258 J. Mingel Vol #: 15
C 1259 D. Farough Vol #: 15
C 1260 J. Williams Vol #: 15
C 1261 S. Proctor Vol #: 15
C 1262 K. Evans Vol #: 15
C 1263 G. Aspenwall Vol #: 15
C 1264 J Johnson Jr Vol #: 15
C 1265 B Wright Vol #: 15
C 1266 G Hackett Vol #: 15
C 1267 M LaFluer Vol #: 15
C 1268 A Redmond Vol #: 15
C 1269 H. Hancock Vol #: 15
C 1270 J. Johnson Vol #: 15
C 1271 D. O'Connell Vol #: 15
C 1272 C. Bowers Vol #: 15
C 1273 E. DeFaleo Vol #: 15
C 1274 R. Szada Vol #: 15
C 1275 B. Groh Vol #: 15
C 1276 P. Porath Vol #: 15
C 1277 M. Vandenberg Vol #: 15
C 1278 F. Tedrick Vol #: 15
C 1279 J. Menga Vol #: 15
C 1280 D. Goodin Vol #: 15
C 1281 M. Sauvveur Vol #: 15
C 1282 B. Haywood Vol #: 15
C 1283 H. Van Horn Vol #: 15
C 1284 J. Hartwell Vol #: 15
C 1285 D Dixon Vol #: 15
C 1286 J. Nunez Vol #: 15
C 1287 B Mills Vol #: 15
C 1288 J. Reynolds Vol #: 15
C 1289 M. Meyer Vol #: 15
C 1290 R. Smith Vol #: 15
C 1291 J O'Brien Vol #: 15
C 1292 J Salva Vol #: 15
C 1293 G. Vayles Vol #: 15
C 1294 G. Pike Vol #: 15
C 1295 M. O'Connor Vol #: 15
C 1296 C. Smith Vol #: 15
C 1297 M. Hagle Vol #: 15
C 1298 E Peet Vol #: 15
C 1299 H. Warren Vol #: 15
C 1300 E. Butcher Vol #: 15
C 1301 D Wilkerson Vol #: 15
C 1302 M Tomerlin Vol #: 15
C 1303 K. Hill Vol #: 15
C 1304 C Walker Vol #: 15
C 1305 P Hobart Vol #: 15
C 1306 D Barough Vol #: 15
C 1307 C. Smole Vol #: 15
C 1308 N. Gilmore Vol #: 15
C 1309 R Lepczyk Vol #: 15
C 1310 D. McKamie Vol #: 15
C 1311 G Sherman Vol #: 15
C 1312 T Lewis Vol #: 15
C 1313 S Ramos Vol #: 15
C 1314 J Morgan Vol #: 15
C 1315 W Head Vol #: 15
C 1316 S Harrison Vol #: 15
C 1317 J Kanoff Vol #: 15
C 1318 P Vella Vol #: 15
C 1319 A Landis Jr Vol #: 15
C 1320 J Colon Vol #: 15
C 1321 G. Powell Vol #: 15
C 1322 E Kroah Vol #: 15
C 1323 W Oestrick Vol #: 15
C 1324 A. Basler Vol #: 15
C 1325 M. Lange Vol #: 1
C 1326 G. McLees Vol #: 15
C 1327 T Copeland Vol #: 15
C 1328 F Palumbo Vol #: 15
C 1329 J Sarsfield Vol #: 15
C 1330 C Kelley Vol #: 15
C 1331 C DeFusco Vol #: 15
C 1332 M. Connors Vol #: 15
C 1333 E Altman Vol #: 15
C 1334 R Reese Vol #: 15
C 1335 V Sonon Vol #: 15
C 1336 D Pester Vol #: 15
C 1337 D Spittgerber Vol #: 15
C 1338 H Sanger Vol #: 15
C 1339 W. Gerst Vol #: 15
C 1340 F Berttand Vol #: 15
C 1341 C. Fulton Vol #: 15
C 1342 B Snodgress Vol #: 15
C 1343 L Maddox Vol #: 15
C 1344 E Schmitt Vol #: 15
C 1345 S. Copeland Vol #: 15
C 1346 J Lane Vol #: 15
C 1347 R Estes Vol #: 15
C 1348 B Davidson Vol #: 15
C 1349 M. Burton Vol #: 15
C 1350 A Wieland Vol #: 15
C 1351 M Turner Vol #: 15
C 1352 H McGuire Vol #: 15
C 1353 E Watson Vol #: 15
C 1354 V Mitchell Vol #: 15
C 1355 B Short Vol #: 15
C 1356 N Wood Vol #: 15
C 1357 B Mikton Vol #: 15
C 1358 L Huff Vol #: 15
C 1359 E Gilbertson Vol #: 15
C 1360 V. Plantico Vol #: 15
EC 28 Mrs. Deborah Singleton Vol #: 16
EC 29 none Vol #: 16
EC 30 None Vol #: 16
EC 31 Ms. Nancy Spuhler Vol #: 16
EC 32 Mrs. Kathryn West Vol #: 16
EC 33 Ms. carol swindell Vol #: 16
EC 34 Mrs. lois brachman Vol #: 16
2006P-0281 Determination of Orudis KT (ketoprofen, 12.5 mg) Oral Tablet
LET 2 FDA/CDER to Camargo Pharmaceutical Services, LLC Vol #: 1
2006P-0379 To urge the FDA's prompt action to cancel the GRAS desgnation for diacetyl
LET 2 NATIONAL JEWISH Medical and Research Center Vol #: 2
2006P-0505 ANDA for Ursodial Capsules USP, 100 mg 200 mg, and 400 mg
AMD 1 Lachman Consultant Services, Inc. Vol #: 1
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
EC 1892 Mrs. Lisa Walker Vol #: 5
EC 1893 Mr. john kropp Vol #: 5
EC 1894 Mrs. Viviane Paolini Vol #: 5
EC 1895 Ms. jacqueline wurn Vol #: 5
EC 1896 Mrs. Donna Spears Vol #: 5
EC 1897 Mr. Douglas Smith Vol #: 5
EC 1898 Ms. Lisa Whalen Vol #: 5
EC 1899 Mr. Sean McKenna Vol #: 5
EC 1900 Mr. Benjamin Hestley Vol #: 5
EC 1901 Ms. Evelyn Harvey Vol #: 5
EC 1902 Mr. William Hillier Vol #: 5
EC 1903 Mr. Gary Radman Vol #: 5
EC 1904 Ms. Brenda Varrasso Vol #: 5
EC 1905 New Era Health LLC Vol #: 5
EC 1906 Miss. Jill Murphy Vol #: 5
EC 1907 Mr. W. Clement Vol #: 5
EC 1908 Ms. Gillian Drake Vol #: 5
EC 1909 Mr. William Shelton Vol #: 5
EC 1910 Mr. Hugh Howard Vol #: 5
EC 1911 Ms. Filomena Concia Vol #: 5
EC 1912 Mr. Ryan Carson Vol #: 5
EC 1913 Ms. Ginger Corbett Vol #: 5
EC 1914 Mr. John Grisaffi Vol #: 5
EC 1915 Jacobi Group Ltd. Vol #: 5
EC 1916 Ms. Kathleen Martin Vol #: 5
EC 1917 Ms. Cynthia Frey Vol #: 5
EC 1918 Ms. Christina Howle Vol #: 5
EC 1919 Mrs. Connie Helms Vol #: 5
EC 1920 Mrs. Suzanne Schmidt Vol #: 5
EC 1921 Mrs. Ann Garcia Vol #: 5
EC 1922 None Vol #: 5
EC 1923 Mr. Mark Romano Vol #: 5
EC 1924 Quantum Injury Vol #: 5
EC 1925 Ms. Sherry Sullivan Vol #: 5
EC 1926 Ms. C J Anderson Vol #: 5
EC 1927 Mr. Albert Glover Vol #: 5
EC 1928 Mrs. Frances Merriott Vol #: 5
EC 1929 Ms. Karen Caldwell Vol #: 5
EC 1930 Ms. Faith Pardue Vol #: 5
EC 1931 Ms. Mars Wall Vol #: 5
EC 1932 Ms. Ruth Mills Vol #: 5
EC 1933 Mr. Beverley Tierney Vol #: 5
EC 1934 Health Freedom Alliance Vol #: 5
EC 1935 Mr. Eddie Braun Vol #: 5
EC 1936 Mrs. Barbara Boyden Vol #: 5
EC 1937 Ms. Marie Green Vol #: 5
EC 1938 Essex Bay Photography Vol #: 5
EC 1939 Mr. Donald gage Vol #: 5
EC 1940 Mrs. s berdan Vol #: 5
EC 1941 Ms. Nancy Armstrong Vol #: 5
EC 1942 Miss. Sara DRISCOLL Vol #: 5
EC 1943 Mr. Patrick Rowe Vol #: 5
EC 1944 Mrs. Sharon Ratzlaff Vol #: 5
EC 1945 Mrs. Sue Carroll Vol #: 5
EC 1946 Dr. Debra Tranberg Vol #: 5
EC 1947 Dr. Jeremy Kaslow Vol #: 5
EC 1948 Mrs. Dorothy Hall Vol #: 5
EC 1949 FDA Vol #: 5
EC 1950 Mr. alan mesher Vol #: 5
EC 1951 Ms. brittney kecxon Vol #: 5
EC 1952 Mr. Michael Young Vol #: 5
EC 1953 Ms. Karen Traber Vol #: 5
EC 1954 Miss. sesame fowler Vol #: 5
EC 1955 Dr. Joshi Franks Vol #: 5
EC 1956 Distributor of Nutritional Supplements Vol #: 5
EC 1957 Mrs. Mary Hunter Vol #: 5
EC 1958 Ms. Nancy Hesse Vol #: 5
EC 1959 Mr. Ted Harrison Vol #: 5
EC 1960 Ms. Diana Whery Vol #: 5
EC 1961 Living Water Wellness Vol #: 5
EC 1962 Ms. Dorothy Vadnais Vol #: 5
EC 1963 Ms. Paula Weisman Vol #: 5
EC 1964 Ms. Eleanor Hayes Vol #: 5
EC 1965 Ms. Theresa DiTullio Vol #: 5
EC 1966 Mrs. Cinda Kavurt Vol #: 5
EC 1967 Mr. David Optekar Vol #: 5
EC 1968 Mrs. Eleanor Smith Vol #: 5
EC 1969 Mr. Aaron Thomas Vol #: 5
EC 1970 None Vol #: 5
EC 1971 Ms. Diana Gillis Vol #: 5
EC 1972 Mrs. Julie Bennett Vol #: 5
EC 1973 Ms. Linda Broadhead Vol #: 5
EC 1974 Mr. Francisco Becerra Vol #: 5
EC 1975 Ms. Andrea Peterson Vol #: 5
EC 1976 Mr. Arthur Hoover Vol #: 5
EC 1977 Mr. michael regis Vol #: 5
EC 1978 Miss. Carolyn Pontikas Vol #: 5
EC 1979 Ms. Pearlann Singleton Vol #: 5
EC 1980 Mr. Barry Laub Vol #: 5
EC 1981 Miss. karen kistler Vol #: 5
EC 1982 Mr. John Moffitt Vol #: 5
EC 1983 Miss. karen kistler Vol #: 5
EC 1984 Mrs. Loretta Browning Vol #: 5
EC 1985 RN Vol #: 5
EC 1986 Mr. Jeff Allen Vol #: 5
EC 1987 Ms. Helen Preston Vol #: 5
EC 1988 Mr. William Stoner Vol #: 5
EC 1989 Mrs. Alene Lindstrand Vol #: 5
EC 1990 Ms. Julie Halpin Vol #: 5
EC 1991 Mr. Bradley Collins Vol #: 5
EC 1992 Mr. Buzz Marcus Vol #: 5
EC 1993 Mrs. Yvette Diaz Vol #: 5
EC 1994 Mr. david Flynn Vol #: 5
EC 1995 Ms. Rose M. Berkowitz Vol #: 5
EC 1996 member of health FreedomFoundation Vol #: 5
EC 1997 Mr. robert rosenfield Vol #: 5
EC 1998 Ms. Margaret Stocking Vol #: 5
EC 1999 Mrs. Deborah La Place Vol #: 5
EC 2000 Dr. Ken Knott Vol #: 5
EC 2001 Mr. mario castaldini Vol #: 5
EC 2002 Mr. mario castaldini Vol #: 5
EC 2003 Dr. Rick Kirschner Vol #: 5
EC 2004 Mr. David George Vol #: 5
EC 2005 Health Freedom Action Vol #: 5
EC 2006 Health Freedom Action Vol #: 5
EC 2007 Ms. Barbara Roberts Vol #: 5
EC 2008 Mr. Brian Fraser Vol #: 5
EC 2009 Ms. Marianne Sonntag Vol #: 5
EC 2010 American Vol #: 5
EC 2011 Mr. James Asmus Vol #: 5
EC 2012 Mrs. Lori Asmus Vol #: 5
EC 2013 Mr. Ken Galitello Vol #: 5
EC 2014 Ms. Claire Libby Vol #: 5
EC 2015 Mrs. Tammy Gardner Vol #: 5
EC 2016 Ms. Barbara Elmore Vol #: 5
EC 2017 Mrs. Peggy Kilgore Vol #: 5
EC 2018 Ms. Genette Henderson Vol #: 5
EC 2019 Ms. Lucille Gordon Vol #: 5
EC 2020 Dr. Peggy Miller Vol #: 5
EC 2021 Mrs. Lorene Marchioli Vol #: 5
EC 2022 Miss. GerneyLee Carter Vol #: 5
EC 2023 Mrs. June McElroy Vol #: 5
EC 2024 Ms. Peneloope Jank Vol #: 5
EC 2025 Mrs. Karen Smith Vol #: 5
EC 2026 Mr. ken bueller Vol #: 5
EC 2027 Ms. Julee Tappero Vol #: 5
EC 2028 Dr. Kristine Taylor Vol #: 5
EC 2029 Mrs. corrina carfizzi Vol #: 5
EC 2030 Mr. Peter Glickman Vol #: 5
EC 2031 Mr. Paul Roberts Vol #: 5
EC 2032 Mr. joe storc Vol #: 5
EC 2033 Mrs. Edythe Shaw Vol #: 5
EC 2034 Ms. Nicole Green Vol #: 5
EC 2035 Mr. Roger Effa Vol #: 5
EC 2036 Miss. Patricia Furness Vol #: 5
EC 2037 Bauman College Vol #: 5
EC 2038 Ms. Christine Lewis Vol #: 5
EC 2039 Mrs. Harriett Campbell Vol #: 5
EC 2040 Mrs. Judith Martz Vol #: 5
EC 2041 Fordham University Vol #: 5
EC 2042 Ms. Lauri Pratt Vol #: 5
EC 2043 Mrs. Elizabeth Zarzycki Vol #: 5
EC 2044 Mrs. Patricia Lammers Vol #: 5
EC 2045 Ms. Kathy Hutchins Vol #: 5
EC 2046 Mrs. joyce baker Vol #: 5
EC 2047 Ms. Tina Brown Vol #: 5
EC 2048 Ms. Virginia Shaknis Vol #: 5
EC 2049 Ms. Christine Allsup Vol #: 5
EC 2050 Mrs. Linda Phillips Vol #: 5
EC 2051 Arbonne International Vol #: 5
EC 2052 Mrs. JOAN FAVORITE Vol #: 5
EC 2053 Mrs. Sarah Yao Vol #: 5
EC 2054 Daniel O'Connnor, Nuticeutical Consultant Vol #: 5
EC 2055 Ms. Victoria Morton Vol #: 5
EC 2056 Ms. Nancy Peregrine NC Vol #: 5
EC 2057 Mrs. Christa Barnickel Vol #: 5
EC 2058 Mr. Peter Goodwin Vol #: 5
EC 2059 Ms. Diane K. Watson Vol #: 5
EC 2060 Mrs. J.G. Punga Vol #: 5
EC 2061 Mr. James F Smith Vol #: 5
EC 2062 Ms. Catherine Greene Vol #: 5
EC 2063 Ms. Catherine Greene Vol #: 5
EC 2064 Ms. Mary Gonnella Vol #: 5
EC 2065 Bauman College Vol #: 5
EC 2066 Ms. Laura Braggiotti Vol #: 5
EC 2067 Ms. Bevel Somotun Vol #: 5
EC 2068 Ms. LOUISE GILMAN Vol #: 5
EC 2069 Mr. EDWARD ANDERSON Vol #: 5
EC 2070 Mr. William Gist Vol #: 5
EC 2071 Ms. Andrea Freeman Vol #: 5
EC 2072 Mrs. Twila Rawson Vol #: 5
EC 2073 Ms. Ann Capotosto Vol #: 5
EC 2074 Miss. Jacqueline Mornan Vol #: 5
EC 2075 Ms. Lynn Ravazzini Vol #: 5
EC 2076 Mrs. JoEllen DeNicola Vol #: 5
EC 2077 Mrs. Lilly Nozinski Vol #: 5
EC 2078 Mrs. Marsha Kidd Vol #: 5
EC 2079 Mrs. Susan Weems Vol #: 5
EC 2080 Mr. Donald Carey-Shaw Vol #: 5
EC 2081 Mr. Vincent J. Young Vol #: 5
EC 2082 Mr. Brent Harshberger Vol #: 5
EC 2083 Ms. Ina Brennan Vol #: 5
EC 2084 Ms. Carol Lutra-Johns Vol #: 5
EC 2085 Ms. Victoria Dickinson Vol #: 5
EC 2086 Ms. aLISA Battaglia Vol #: 5
EC 2087 Ms. N Schulz Vol #: 5
EC 2088 Mrs. Pamela Wellborn Vol #: 5
EC 2089 Ms. Ellen Amba Caldwell Vol #: 5
EC 2090 Ms. Sue Acer Vol #: 5
EC 2091 Mr. Rod Peirson Vol #: 5
EC 2092 Ms. Linda K Vol #: 5
EC 2093 Mrs. M Wood Vol #: 5
EC 2094 Mr. Richard Johnson Vol #: 5
EC 2095 Mr. Bruce Gardner Vol #: 5
EC 2096 Mr. William Hedal Vol #: 5
EC 2097 Ms. Bea Workman Vol #: 5
2007D-0168 Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
LET 1 Natco Pharma Limited Vol #: 1
2007D-0173 Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
C 6 PhRMA Vol #: 1
2007N-0236 Agency Information Collection Activities; Proposed Collection; Comment Request; New Animal Drug Applications and Supporting Regulations, and Form FDA 356V
EC 1 Mrs. Janice Carey Vol #: 1
2007N-0264 Revisions to the Requirements Applicable to Blood, Blood Components and Source Plasma, Direct Final Rule
EREG 1 Y.Yogi Vol #: 1
2007N-0317 Agency Information Collection Activities; Proposed Collection; Comment Request, Guidance for Industry on Pharmacogenomic Data Submissions; Extension
N 1 FDA Vol #: 1
2007P-0065 To increase print size of direct-to-consumer advertisements
LET 2 FDA/CDER to Pharmacists Planning Service, Inc. Vol #: 1
2007V-0222 Projector for a Laser Light Show
VRA 1 FDA/CDRH to Tempest International LLC Vol #: 1

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