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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…
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance
FOR INDUSTRY This guidance document is for comment purposes only.  Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food…
Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry
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Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance
FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF   This guidance document is for comment purposes only.  Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit electronic comments to http://www.regulations.gov.  Submit written comments…
Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Draft Guidance for Industry and Food and Drug Administration Staff
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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…
Printable Version: Bacterial Detection Testing by Blood and Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Draft Guidance for Industry
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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…