[10/22/2015] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) está advirtiendo que los tratamientos de Viekira Pak y Technivie contra la hepatitis C pueden causar daños hepáticos graves, sobre todo en pacientes con una enfermedad del hígado subyacente en etapa avanzada. En consecuencia, estamos exigiéndole al fabricante […]

[04/12/2015] Una reciente evaluación de seguridad realizada por la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) ha llevado a la adición de advertencias a las etiquetas de una clase específica de medicamentos para la diabetes de tipo 2, llamados inhibidores del cotransportador de sodio-glucosa tipo 2 (SGLT2, […]

Information about Over-the-Counter (OTC) Monograph Reform

A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations.

Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop

Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016.

Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc.

Generic Drug Facilities, Sites and Organization Lists

The Food and Drug Administration is advising consumers not to purchase or use Vy & Tea, a product promoted and sold for weight loss on various websites, including www.vyteaus.com, and possibly in some retail stores.

The Food and Drug Administration (FDA) is advising consumers not to purchase or use Super Slim, a product promoted and sold for weight loss on various websites, including eBay.com, and possibly in some retail stores.