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PET Drugs–Current Good Manufacturing Practice (CGMP); Small Entity Compliance Guide
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User Fee Waivers, Reductions, and Refunds for Drug and Biological Products
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FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug
Safety Announcement Additional Information for Patients Additional Information for Healthcare Professionals Data Summary  Safety Announcement [03-12-2010] The U.S. Food and Drug Administration (FDA) has added a Boxed Warning to the label for Plavix, the anti-blood clotting medication. The Boxed Warning is about patients who do not effectively metabolize the drug (i.e. “poor metabolizers”) and…
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA informa que el psicofármaco ziprasidona (Geodon) está relacionado con reacciones cutáneas poco comunes, pero potencialmente fatales
La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que el fármaco antipsicótico ziprasidona (a la venta con el nombre comercial de Geodon, y sus versiones genéricas) está relacionado con una reacción cutánea poco común, pero grave, que puede avanzar y afectar otras partes del cuerpo. Se…
FDA Drug Safety Communication: FDA reporting mental health drug ziprasidone (Geodon) associated with rare but potentially fatal skin reactions
The U.S. Food and Drug Administration (FDA) is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe…
La FDA advierte sobre un caso de LMP, una infección cerebral poco común, con el fármaco Tecfidera (dimetilfumarato) para la esclerosis múltiple
La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) de los Estados Unidos está advirtiendo que una paciente con esclerosis múltiple (EM) a la que se estaba tratando con Tecfidera (dimetilfumarato) contrajo una infección cerebral grave y poco común conocida como LMP, y luego falleció. En consecuencia, se están añadiendo una descripción…
FDA Drug Safety Communication: FDA warns about case of rare brain infection PML with MS drug Tecfidera (dimethyl fumarate)
[11-25-2014] The U.S. Food and Drug Administration (FDA) is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed a rare and serious brain infection called PML, and later died. As a result, information describing this case of PML, or progressive multifocal leukoencephalopathy, is being added to the…
Key Points of the Bad Ad Program
What is the Bad Ad Program? The Bad Ad Program is an FDA-sponsored outreach program designed to educate health care professionals about the role they can play in helping FDA ensure that prescription drug advertising and promotion is truthful and not misleading. The program helps health care professionals who prescribe medications or otherwise make selection…
FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events
A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, we have added information about these…