21 junio 2017

FDA . Agenda : On June 21, 2017 . PM01183 Figura en el Orden del Día para Evaluar su posible I+D Pediatrica .

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DEPARTMENT OF HEALTH AND HUMAN SERVICES // Food and Drug Administration ( FDA ) .

[Docket No. FDA-2017-N-2731]

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments .

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

Agenda : On June 21, 2017 .

Information will be presented to gauge investigator interest in exploring potential pediatric development plans for three products in various stages of development for adult cancer indications.

The subcommittee will consider and discuss issues concerning diseases to be studied, patient populations to be included, and possible study designs in the development of these products for pediatric use.

The discussion will also provide information to the Agency pertinent to the formulation of written requests for pediatric studies, if appropriate.

The products under consideration are:

*.- APX-005M, Presentation by Apexigen, INC .

*.- PMO1183 ( Lurbinectedin ), Presentation by PharmaMar USA INC .

*.- ASP2215 (gilteritinib), Presentation by Astellas Pharma Global Development, INC .