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Dockets Management

Dockets Entered On September 10, 2007
Docket # Title
1978N-0038 Sunscreen Drug Products
2000D-1598 Voluntary Labeling for Bioengineered Foods
2004P-0562 Request immediate recall of all unapproved methacholine chloride products
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
2006P-0394 Revise the labeling requirements for eggs sold in the United States
2007A-0087 Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
2007D-0212 Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
2007P-0079 To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
1978N-0038 Sunscreen Drug Products
EC 2353 Dr. Nina Tomei Vol #: 161
EC 2354 Image International Vol #: 161
EC 2355 Image International Vol #: 161
EC 2356 Ms. Carol Kirkbride Vol #: 161
EC 2357 Mrs. Ann Yasko Vol #: 161
EC 2358 Mrs. Jill Feinstein Vol #: 161
EC 2359 Ms. Gale C Georgalas Vol #: 161
EC 2360 Ms. Julia Chen Vol #: 161
EC 2361 Mr. Harold Farmer Vol #: 161
EC 2362 Mrs. cheryl stank Vol #: 161
EC 2363 Mrs. Caryn Craig Vol #: 161
EC 2364 Mrs. Theresa Pileggi Vol #: 161
EC 2365 Ms. caitlin haynes Vol #: 161
EC 2366 Ms. Mishell Coffman Vol #: 161
EC 2367 Mrs. Robin Meese Vol #: 161
EC 2368 Ms. Audrey Steiner Vol #: 161
EC 2369 Ms. Kathryn Dillon Vol #: 161
EC 2370 Ms. Seatree Osage Vol #: 161
EC 2371 Ms. Joanne Blythe Vol #: 161
EC 2372 Mr. vincent scerbo Vol #: 161
EC 2373 Mrs. Paia Palmer Vol #: 161
EC 2374 Mr. Jason Feldman Vol #: 161
EC 2375 Ms. Michelle Paquette Vol #: 161
2000D-1598 Voluntary Labeling for Bioengineered Foods
C 10019 Joy Maniscalco Vol #: 580
2004P-0562 Request immediate recall of all unapproved methacholine chloride products
PDN 1 Margaret O'K. Glavin Vol #: 1
2005P-0411 Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
C 18336 J. Baxter Vol #: 198
2006D-0347 Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays
C 23 ThermoFisher SCIENTIFIC Vol #: 3
2006P-0158 Revoke regulations that provided for the inclusion and addition of sucralose as a non-nutritive sweetener in food
EMC 171 Joanne Dahill Vol #: 1
EMC 172 Gerry Foley Vol #: 1
EMC 173 Evelyn Craig Vol #: 1
EMC 174 Barrie MacLauchlin Vol #: 1
EMC 175 Despina Menon Vol #: 1
EMC 176 Jerome Taub Vol #: 1
EMC 177 Nathan Booker Vol #: 1
EMC 178 Susan Kieklak Vol #: 1
EMC 179 Lynn Congo Vol #: 1
EMC 180 Kathy Mclean Vol #: 1
EMC 181 Mary Thrantell Vol #: 1
EMC 182 Meghen A. Vance Vol #: 1
EMC 183 Deborah Mattox Vol #: 1
EMC 184 Luann Stubbs Vol #: 1
EMC 185 Marilyn Bernstein Vol #: 1
EMC 186 Jane Mauer Vol #: 1
EMC 187 Ann Fonfa Vol #: 1
EMC 188 Lynn Congo Vol #: 1
EMC 189 Cherly Winberg Vol #: 1
EMC 190 Martha Humphrey Vol #: 1
EMC 191 John F. Ingrassia Vol #: 1
EMC 192 Karen Conrad Vol #: 1
EMC 193 Wendy Meere Vol #: 1
EMC 194 L Bagley Vol #: 1
EMC 195 Galen Eldridge Vol #: 1
EMC 196 Brenda Davis Vol #: 1
EMC 197 Melissa Freeman Vol #: 1
EMC 198 Bonnie Vock Vol #: 1
EMC 199 Dorothy Davis Vol #: 1
EMC 200 Gerry Foley Vol #: 1
EMC 201 Davina Colvin Vol #: 1
EMC 202 Diana Peterlin Vol #: 1
EMC 203 Charles Morris Vol #: 1
EMC 204 Rebecca Scherbarth Vol #: 1
EMC 205 Penny Prentice-Best Vol #: 1
EMC 206 Bina Robinson Vol #: 1
EMC 207 Charlotte Hawkins Vol #: 1
EMC 208 Michael Yannell Vol #: 1
EMC 209 Phyllis Bala Vol #: 1
EMC 210 Sandra Boothe Vol #: 1
2006P-0394 Revise the labeling requirements for eggs sold in the United States
C 144 Jorge Lopez Vol #: 7
2007A-0087 Request for an advisory opinion with respect to the FDA's interpretation of 21CFR314.70(c)(6)(iii) regarding NDAs to implement safety-related changes to prescription drug labeling
LET 1 Jane A. Axelrad Vol #: 1
2007D-0125 Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
EC 2356 Martek Biosciences Corporation Vol #: 18
EC 2357 American Association for Health Freedom Vol #: 18
EC 2358 Center for Science in the Public Interest Vol #: 18
EC 2359 TREA Senior Citizens League Vol #: 18
EC 2360 HERB PHARM INC. Vol #: 18
EC 2361 American Heart Association Vol #: 18
EC 2362 Natural Products Association Vol #: 18
2007D-0212 Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis
EC 1 Walter Reed Army Institute of Research Vol #: 1
EC 2 Sanofi-Aventis Vol #: 1
2007P-0047 Amend the Dosage of Oral Phenylephrine Listed in the Final Monogrph on Oral Decongestants
LET 1 FDA/CDER to the University of Florida Vol #: 1
2007P-0079 To sanction third party independent scientific analysis of zine gluconate (ZICAM) additional safety standards for the homeopathic industry
LET 1 Jane A. Axelrad Vol #: 1

Page created on September 10, 2007 ue

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