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January 27, 2021

FDA Updates and Press Announcements on Nitrosamines in Rifampin and Rifapentine

[8/26/2020] These are antibacterial drugs used to treat tuberculosis; rifampin is also used to treat or prevent other serious infections. Patients taking rifampin or rifapentine should […]
January 27, 2021

FDA Approves Cabenuva and Vocabria for the Treatment of HIV-1 Infection

FDA approved CABENUVA (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use. This is the first FDA-approved injectable, complete regimen for HIV-1 infected […]
January 27, 2021

July – September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Actemra (tocilizumab) Hepatitis B reactivation FDA is evaluating the need for regulatory action. Alcohol containing hand sanitizers Blood methanol induced blindness and death Regulatory actions taken. […]
January 26, 2021

Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers

For Immediate Release: January 26, 2021 Español As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent […]
January 26, 2021

Coronavirus (COVID-19) Update: January 26, 2021

For Immediate Release: January 26, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
January 26, 2021

Comunicado de la FDA sobre la seguridad de los medicamentos: Información actualizada sobre la dosis intravenosa de 32 mg de ondansetrón (Zofran) y productos previamente mezclados de ondansetrón

Esta actualización se hace a manera de seguimiento al Comunicado sobre la seguridad de los medicamentos de la FDA: Nueva información sobre la prolongación del intervalo […]
January 26, 2021

Activities Report of the Generic Drugs Program (FY 2020) – FDARA Title VIII Section 807 and 805

Section 807 of the FDA Reauthorization Act of 2017(FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under […]
January 26, 2021

Activities Report of the Generic Drugs Program (FY 2019) – FDARA Title VIII Section 807 and 805

Section 807 of the FDA Reauthorization Act of 2017(FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under […]
January 26, 2021

DDT COA #000005: Diary for Irritable Bowel Syndrome Symptoms – Constipation (DIBSS-C)

Qualified Clinical Outcome Assessments (COA)Office of Immunology and Inflammation (OII)Division of Gastroenterology DDT COA NumberDDT COA #000005 Instrument NameDiary for Irritable Bowel Syndrome Symptoms – Constipation […]
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