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January 19, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte que el medicamento antipirético y analgésico acetaminofén (paracetamol) puede causar reacciones poco comunes pero serias en la piel

Anuncio de seguridad El primero de agosto, 2013, La Administración de Alimentos y Medicamentos (FDA por sus siglas en inglés), informó al público que se ha […]
January 19, 2021

Individual Patient Expanded Access Applications: Form FDA 3926

Docket Number: FDA-2015-D-0268 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes From FDA 39262 (Individual Patient Expanded Access – Investigational […]
January 19, 2021

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19)

Docket Number: FDA-2020-D-2016 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Center for Veterinary Medicine The Food […]
January 19, 2021

Bodyhealth.com, LLC – 610728 – 12/09/2020

Delivery Method: VIA UNITED PARCEL SERVICE Product: DrugsFood & Beverages Recipient: Recipient Name Mr. David Minkoff Recipient Title Registered Agent Bodyhealth.com, LLC 707 Cleveland St.Clearwater, FL […]
January 15, 2021

Coronavirus (COVID-19) Update: January 15, 2021

For Immediate Release: January 15, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
January 15, 2021

FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas

On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or […]
January 15, 2021

Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs and Colin Rom, Senior Advisor to the Commissioner Remember in-person meetings? A year ago, would […]
January 15, 2021

What happens after a Patient Listening Session?

Thank you for taking the time to participate in a Patient Listening Session! Patient Listening Sessions help FDA understand what is important to the patient community […]
January 15, 2021

How do I prepare for a Patient Listening Session?

Participants parking at FDA should arrive at the visitor parking lot an hour and 15 minutes before the start of the session. While driving to the […]
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