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January 4, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Actualización sobre el riesgo de eventos severos de hemorragia con el anticoagulante Pradaxa (dabigatrán etexilato mesilato)

Esta actualización se hace a manera de seguimiento al Comunicado de la FDA sobre la seguridad de los medicamentos del 7/12/2011: Estudio de seguridad sobre informes […]
January 4, 2021

Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol

Summary Company Announcement Date: January 04, 2021 FDA Publish Date: January 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Contaminated with Methanol Company […]
January 2, 2021

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Due to Microbial Contamination

Summary Company Announcement Date: December 31, 2020 FDA Publish Date: December 31, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia […]
December 30, 2020

Coronavirus (COVID-19) Update: December 30, 2020

For Immediate Release: December 30, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
December 30, 2020

2020 at FDA: A Year of Unparalleled Contributions to Public Health

Image By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs It has been a year like no other in recent memory for public health. At […]
December 30, 2020

Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry

Docket Number: FDA-2016-N-0124 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to help small businesses understand and comply with […]
December 29, 2020

February 9, 2021: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement – 02/09/2021 – 02/09/2021

On This Page Date: February 9, 2021 Time: 10:00 AM – 2:00 PM ET Center Date Time Location CDER February 9, 2021 10:00 a.m. to 2:00 p.m.  […]
December 29, 2020

2018 Meeting Materials, Oncologic Drugs Advisory Committee

2018 Meeting Materials, Oncologic Drugs Advisory Committee | FDA In this section: Oncologic Drugs Advisory Committee Home Advisory Committees Committees and Meeting Materials Human Drug Advisory […]
December 29, 2020

2016 Meeting Materials, Oncologic Drugs Advisory Committee

2016 Meeting Materials, Oncologic Drugs Advisory Committee | FDA In this section: Oncologic Drugs Advisory Committee Home Advisory Committees Committees and Meeting Materials Human Drug Advisory […]
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