"lB FAX OTC CENTER DIVISION OF OTC DRUG PRODUCTS"
06/21/2004 J5:lB'FAX 3018272316 OTC RIO02 DIVISION OF OTC DRUG PRODUCTS CENTER FORDRUG 3ON AND RESEARCH EVALUAi’ ANNOUNCEMENT OF OTC DRUG FEEDBAGK MEETING ,;2 ,I. BETWEEN: Representatives of FDA Consumer Healthcare Products Association Douglas Ws. .#iercr, Ph.D., Vice President, Regulatory and Scientjlfic Affairs Del Pharmaceuticais, In% Charles J. HSnkraty>President Swap Ozelkan, Ph.D., Director, PharmaceuticalsResearch Patricia Suita-Cruce, Ph.D., VScePres, Pharmaceuticals, Research & Development Randy M. Slo&n, Senior Vice President, Market@ William 0. Thompson, Ph.D., Professor and Director Emeritus oSBiostatistics, Medical. College of Georgia William E. Cooley, Ph.D-, President, Co&y Carwlting, Inc. Wyeth Consumer Healthcare Stephen A. Cooper, DMD., Ph.D., Sr. V-P,, Global CIinicaI and Medical Affairs Margaret S, Hughes, Ph.D., Associate Director, F&gulatory Affairs M.. Sudam Pathiraua, PLD., Clinical Research Scientist Alan 3% Stokes, Ph-D,, D,A,B,~=, Senior Manager, Regulatory Affairs Joel Waksman, Ph.D., Assistant Vice President, Biostatisties and Data Management TOPIC: Proposed labeling and clinlcai data on benzocaine in toothache reiicf DATE: June 28,2004 TIME: 1~30 p.m. LOCATION: Corporate 2 - Conference Room S 400 9201 Corporate Boulevard Rockville, Maryhmd s Pursuant to the agency’ policy statement published iu the FEDERAL REGIsTlER of September 29,1981(46 FR 47740) and elariiled April 1,1983 (48 FR 14050) and February 4,1985 (50 FIX 4916), which includes provisions for agency meetings with industry or other fnterested persons; this feedback meeting is being announced. All feedback meemgs are open to the public and no prior reservatiom 9s necessary. For fu&er information or to recortfilrm that the mectiug has not been rescheduled or canceled, call Elaine Abraham, 301-827-2222. ATTENTION: JENNIE BUTLER Docket Ho. SON-0295 ;iTE FORWARDED: 6/21/04 06/21/2OQ4 JS:.18 ‘ FAX 3018272316 OTC Boo1 MEMORANDUM DEPARTMENT AND HUMAN SERVICCES OF HEALTH PUBLXC HEALTH $I#RVICE FO?D AND DRUG ADMINISTRATION CEliTER FOR DRUG EVALUATION AND RESEARCH DATE: FROM: Director Division of OTC Drug Products, HFD-560 SUBJECT; Material for Docket No, gw-oz~~- . TO: Dockets Management Branch, WFA-305 : The attached material should be placed on pubiic !d display under the above referenced Docket No. cl This material Comment No * should be cross-referenced to Attachment