Esta traducción se está preparando. Mientras tanto, mostramos temporalmente la versión original en inglés.
Negocios · 5/12/20191 min de lectura
Interstitial Cystitis/Bladder Pain Syndrome: Establishing Effectiveness of Drugs for Treatment; Draft Guidance for Industry; Availability
Traducción automática local · Idioma original de la fuente
Resumen
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS): Establishing Effectiveness of Drugs for Treatment." There is pharmaceutical and stakeholder interest in the development of new drugs for patients with IC/BPS. This draft guidance provides FDA's recommendations for clinical trials intended to establish clinical effectiveness and safety for drugs intended to treat IC/BPS.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →