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January 8, 2021

Dr. Hahn’s remarks to the Alliance for Health Policy Brazda Breakfast Briefing – 01/08/2021

Speech by Stephen M. Hahn, M.D. Leadership Role Commissioner of Food and Drugs – Food and Drug Administration (Remarks as prepared for delivery) Good morning and […]
January 8, 2021

New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products

Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) […]
January 8, 2021

New Drug Therapy Approvals 2020

IMPACT  INNOVATION  PREDICTABILITY  ACCESSFDA’s Center for Drug Evaluation and ResearchJanuary 2021 Director’s Message Welcome to the FDA’s Center for Drug Evaluation and Research’s (CDER’s) annual report, […]
January 8, 2021

FDA Drug Safety Communication: New information regarding QT prolongation with ondansetron (Zofran)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary Safety Announcement [06-29-2012] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the […]
January 7, 2021

FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie

The U.S. Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with […]
January 7, 2021

FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin

The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing […]
January 7, 2021

FDA Drug Safety Communication: FDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks

We conducted a drug utilization analysis of concomitant use of benzodiazepines with buprenorphine products being used for medication-assisted treatment (MAT), using the Prescription Behavior Surveillance System’s […]
January 7, 2021

FDA Drug Safety Communication: FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women

CodeineA search of the FDA Adverse Event Reporting System (FAERS) database from January 1969 to May 2015 identified 64 worldwide cases of respiratory depression, including 24 […]
January 7, 2021

FDA Drug Safety Communication: Abnormal heart rhythms associated with high doses of Celexa (citalopram hydrobromide)

Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary  Safety Announcement [8-24-2011] The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and patients […]
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