United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2014_register executive 2014-10-07 article Notices D09002ee1c7f86b98 D09002ee1c7f86c32 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing a public meeting and scientific workshop, both of which will provide an opportunity for public comment on the topic of Female Sexual Interest/ Arousal Disorder (FSIAD), the most common form of female sexual dysfunction. FSIAD is a diagnosis that combines two previously distinct disorders--hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD). The public meeting will take place on October 27, 2014, and is part of FDA's Patient-Focused Drug Development performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will obtain patients' perspectives on the impact that FSIAD (or a prior diagnosis of HSDD or FSAD) has on their daily lives, as well as their perspectives on the available therapies for these conditions. The scientific workshop will take place on October 28, 2014, and will provide an opportunity for FDA to seek input from experts on scientific issues important to the clinical development of drug products intended to treat FSIAD. 79 FR 57942 https://www.govinfo.gov/app/details/FR-2014-09-26/2014-22983 2014-22983 fr26se14-74 4164-01-P Docket No. FDA-2014-N-1413 https://www.govinfo.gov/app/details/FR-2014-09-26/2014-22983 https://www.govinfo.gov/content/pkg/FR-2014-09-26/html/2014-22983.htm https://www.govinfo.gov/content/pkg/FR-2014-09-26/pdf/2014-22983.pdf 3 p. 57942 57944 79 FR 57942 Patient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction; Federal Register Vol. 79, Issue NOTICE 2014-22983 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2014-12-29 2014-10-27 Docket No. FDA-2014-N-1413 4164-01-P 2014-22983 Notice of public meeting and workshop; request for comments.

The Food and Drug Administration (FDA) is announcing a public meeting and scientific workshop, both of which will provide an opportunity for public comment on the topic of Female Sexual Interest/ Arousal Disorder (FSIAD), the most common form of female sexual dysfunction. FSIAD is a diagnosis that combines two previously distinct disorders--hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD). The public meeting will take place on October 27, 2014, and is part of FDA's Patient-Focused Drug Development performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). At this meeting, FDA will obtain patients' perspectives on the impact that FSIAD (or a prior diagnosis of HSDD or FSAD) has on their daily lives, as well as their perspectives on the available therapies for these conditions. The scientific workshop will take place on October 28, 2014, and will provide an opportunity for FDA to seek input from experts on scientific issues important to the clinical development of drug products intended to treat FSIAD.

The meeting will be held on October 27, 2014, from 12 p.m. to 5 p.m. and the workshop will be held on October 28, 2014, from 8 a.m. to 5 p.m. Registration to attend either the meeting or the workshop must be received by October 17, 2014. See the SUPPLEMENTARY INFORMATION section for information on how to register for either the meeting or the workshop. Submit electronic or written comments by December 29, 2014. For questions regarding the October 27 Patient-Focused Drug Development meeting: Pujita Vaidya, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1144, Silver Spring, MD 20993, 301-796-0684, FAX: 301-847-8443, Pujita.Vaidya@fda.hhs.gov. Meetings: Patient-Focused Drug Development and Scientific Workshop on Female Sexual Dysfunction , Charlene.Williamson@fda.hhs.gov PatientFocused@fda.hhs.gov Pujita.Vaidya@fda.hhs.gov http://fsdpatientfocused.eventbrite.com http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf http://www.fda.gov/Drugs/NewsEvents/ucm401167.htm http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm http://www.regulations.gov www.regulations.gov Vol. 79, no. 187 Office of the Federal Register, National Archives and Records Administration 2014-09-26 continuing daily deposited born digital 550 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2014-09-26 P0b002ee189db152e 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr26se14 https://www.govinfo.gov/app/details/FR-2014-09-26 https://www.govinfo.gov/content/pkg/FR-2014-09-26/pdf/FR-2014-09-26.pdf https://www.govinfo.gov/content/pkg/FR-2014-09-26/xml/FR-2014-09-26.xml fdlp 57699 58240 DGPO 2014-10-07 2024-06-02 FR-2014-09-26 machine generated eng FR FR-2014-09-26 79 187