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January 15, 2021

Mytilini Enterprises LLC dba Bedford Pharmacy Inc. – 486159 – 01/11/2021

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Charles J. Fanaras Recipient Title President Mytilini Enterprises LLC dba Bedford Pharmacy Inc. 209 Route 101Bedford, […]
January 15, 2021

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) […]
January 15, 2021

How does FDA benefit from Patient Listening Sessions?

Patient Listening Sessions help FDA understand what is important to patients, caregivers, and patient advocates when medical products are being developed. The Office of Patient Affairs […]
January 15, 2021

FDA approves crizotinib for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

On January 14, 2021, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults […]
January 14, 2021

FDA-ASCO Virtual Workshop Defining a Research Agenda to Address Barriers and Solutions to Oral Anticancer Agent Adherence – 02/02/2021 – 02/03/2021

On This Page Date: February 2 – 3, 2021 Day1: Tue, Feb 2 1:00 PM – 4:30 PM ET Day2: Wed, Feb 3 1:00 PM – […]
January 14, 2021

Pandemic Response, Pandemic Preparation

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs Over the past year, […]
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 […]
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