Provision Consulting GroupApr 7, 20213 minFDA NewsNew OTC Monograph User Fees for FY2021 is AnnouncedBACKGROUND On March 27, 2020, "the Coronavirus Aid, Relief, and Economic Security Act" (CARES Act) was signed into law. Section 744M of...
Provision Consulting GroupMar 24, 20212 minFDA NewsFDA Alerts Public about Improper Use of Thermal Imaging DevicesThe U.S. Food and Drug Administration alerted public of thermal imaging systems intended to measure human body temperature—also known as...
Provision Consulting GroupMar 18, 20212 minFDA NewsFDA Granted Marketing Authorization of First COVID-19 Diagnostic Test Using De Novo Review PathwayOn March 17, 2021, the U.S Food and Drug Administration permits marketing authorization of the BioFire Respiratory Panel 2.1 (RP 2.1)....
Provision Consulting GroupFeb 25, 20212 minFDA NewsHomemade Infant Formula is not recommended by the FDAOn February 24, 2021, the FDA advises parents and caregivers to not make or feed homemade infant formula to infants. The FDA said that...
Provision Consulting GroupFeb 17, 20212 minFDA NewsFDA Warns Seriously Toxic Hand Sanitizers Imported from MexicoThe Food and Drug Administration has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert. It is the first...
Provision Consulting GroupJan 29, 20212 minFDA NewsFDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIVOn January 21, The U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a...