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January 13, 2021

COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research FDA plays a critical role in protecting the United States from threats […]
January 13, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte de graves reacciones de la piel con el medicamento anticonvulsivo Onfi (clobazam) y ha aprobado cambios a la etiqueta

Haga clic aquí para ver o imprimir una copia de este comunicado sobre la seguridad de los medicamentos – [PDF – 105KB] Anuncio de seguridad La […]
January 13, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Estudio de seguridad en curso sobre el medicamento Mirapex (pramipexole) para la enfermedad de Parkinson y el posible riesgo de insuficiencia cardíaca

Anuncio de seguridadInformación adicional para consumidoresInformación adicional para profesionales de la saludResumen de datosReferencias Anuncio de seguridad 19 de septiembre del 2012. La Administración de Alimentos […]
January 13, 2021

Drug Master File (DMF) Submissions on New FDA Form 3938 – 01/13/2021 – 01/13/2021

On This Page Date: January 13, 2021 Time: 12:00 PM – 1:00 PM ET [embedded content] Download Slides How will eCTD format requirements and Form 3938 […]
January 13, 2021

CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Drug Shortage Mitigation Efforts

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of […]
January 12, 2021

Database of Pharmacogenomic Information in Ethnic Minority Populations (dbPGxEMP)

Description Differences in genes can make someone more or less likely to benefit from a drug, suffer side effects, or require a dose that is different […]
January 12, 2021

Workshop on Evaluating RWE from Observational Studies in Regulatory Decision-Making – 02/16/2021 – 02/17/2021

On This Page Date: February 16 – 17, 2021 Day1: Tue, Feb 16 1:00 PM – 5:00 PM ET Day2: Wed, Feb 17 1:00 PM – […]
January 12, 2021

Infuscience, Inc. dba Bioscrip Infusion Services – 609526 – 12/21/2020

Delivery Method: Electronic Email Product: Drugs Recipient: Recipient Name Alan Theriault Recipient Title Pharmacy Manager Infuscience, Inc. dba Bioscrip Infusion Services 4151 Lafayette Center Drive, Suite […]
January 12, 2021

Smarter Nutrition, Inc. – 610024 – 12/28/2020

Delivery Method: United Parcel Service Product: DrugsFood & Beverages Recipient: Recipient Name Daqing Goa Recipient Title President Smarter Nutrition, Inc. 17870 Newhope St. Suite 104-480Fountain Valley, […]
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