Meeting of the Advisory Committee for Reproductive Health Drugs January 23 and 24, 2007

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2. Degree and Purpose of Meeting. ScopeGeneral meeting on oral and non-oral (i.e., transdermal and intravaginal) hormonal prophylactic productsObjectivesObtain exhortation on issues that should be agreeably tended to amid administrative audit preceding approvalObtain counsel to help Division in adding to a clinical trial Guidance Document for hormonal contraceptives Currently no FDA clinical t

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Slide 1

´╗┐Meeting of the Advisory Committee for Reproductive Health Drugs January 23 and 24, 2007 Scott Monroe, MD Acting Director, Division of Reproductive and Urologic Products

Slide 2

Scope and Purpose of Meeting Scope General meeting on oral and non-oral (i.e., transdermal and intravaginal) hormonal prophylactic items Objectives Obtain exhortation on issues that should be attractively tended to amid administrative audit before endorsement Obtain counsel to help Division in building up a clinical trial Guidance Document for hormonal contraceptives Currently no FDA clinical trial Guidance Document for these items

Slide 3

Topics to be Discussed Clinical trial configuration issues Assessment of preventative adequacy and general hazard/advantage Translation of clinical trial discoveries of viability and security into "certifiable" viability and wellbeing Cycle control (booked and unscheduled draining or spotting) and different measures of item agreeableness to the client

Slide 4

Topics to be Discussed Extended dosing regimens Post-endorsement (Phase 4) responsibilities for further examination Generally for remarkable yet genuine security issues Role and effect of naming for correspondence of clinical trial discoveries to incorporate Product adequacy, chance, and other potential advantages

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Agenda (Day 1) 9:00 Clinical Trial Design Issues (Dr. Cost) 11:00 Break 11:15 Efficacy and Risk/Benefit (Drs. Trussell/Gillen) 12:30 Lunch 1:30 Continue Discussion of Morning Topics 2:45 Break 3:00 Translation of Clinical Trial Findings to the "Real World" (Drs. Gilliam and Hillard) 5:00 Bleeding/Spotting Issues (Dr. Trussell) 6:00 Adjournment

Slide 6

Agenda (Day 2) Extended Dosing Regimens Phase 4 Commitments Role and Impact of Labeling Presentations by Organizations and Individuals

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