Archive for January, 2021

Coronavirus (COVID-19) Update: January 29, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: This week, the FDA…

Coronavirus (COVID-19) Update: 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 pandemic: The agency has updated…

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

As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed…

Coronavirus (COVID-19) Update: January 22, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA’s Office of…

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus…

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

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: Today, to help protect…

FDA Marks Historic Public Health Milestone with Finalization of Two Key Rules for Companies Seeking to Market New Tobacco Products

On January 19, 2021, the Premarket Tobacco Product Applications final rule and Substantial Equivalence final rule were displayed in the Federal Register, but did not…

Coronavirus (COVID-19) Update: 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 pandemic: Today, the FDA issued…

Federal judge enters consent decree against Washington state juice processor

The U.S. District Court for the Eastern District of Washington entered a consent decree between the U.S. Food and Drug Administration (FDA) and Valley Processing,…

FDA Warns Firms to Remove Unauthorized E-liquid Products from Market in First Letters Issued to Manufacturers that Did Not Submit Premarket Applications by Deadline

Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products,…