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February 2, 2021

rx2go.com – 612391 – 01/28/2021

Product: Drugs Recipient: rx2go.com United States Issuing Office: Center for Drug Evaluation and Research | CDER United States TO: www.rx2go.com FROM: The United States Food and […]
February 2, 2021

American Global Health Group, LLC – 610283 – 01/22/2021

Delivery Method: Overnight Delivery Product: DrugsFood & Beverages Recipient: Recipient Name Jonathan Jewett Recipient Title Chief Executive Officer American Global Health Group, LLC 11808 Northup Way, […]
February 2, 2021

Grupo Yacana Mexico, S.A.S. de C.V. – 609824 – 01/26/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Sofia Corona Gonzalez Recipient Title Laboratory and Production Manager Grupo Yacana Mexico, S.A.S. de C.V. Av. […]
February 2, 2021

Generic Drugs Forum 2021: Lifecycle of a Generic Drug – 04/28/2021 – 04/29/2021

On This Page Date: April 28 – 29, 2021 Time: 8:00 AM – 4:00 PM ET Subscribe for Conference Updates   Subscribe to be notified when […]
February 1, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA advierte del aumento del riesgo de muerte con antibiótico Tygacil intravenoso (tigeciclina) y aprueba nuevo Recuadro con advertencia

Esta actualización se hace a manera de seguimiento al Comunicado de la FDA sobre la seguridad del medicamento: Mayor riesgo de muerte con Tygacil (tigeciclina) en […]
February 1, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: la FDA aclara el uso pediátrico de Revatio (sildenafil) para la hipertensión arterial pulmonar

Esta información se hace a manera de seguimiento al Comunicado de la FDA sobre la Seguridad de los Medicamentos emitido el 30 de agosto del 2012. […]
February 1, 2021

Good Laboratory Practice Regulations Questions and Answers

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Since June 20, 1979, the agency has been asked many questions on the Good Laboratory […]
February 1, 2021

Potassium Iodide Tablets – Shelf Life Extension

Docket Number: FDA-2003-D-0029 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document is intended to provide guidance to Federal agencies and to […]
February 1, 2021

Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

Docket Number: FDA-2011-D-0868 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Devices and Radiological Health […]
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