Posts published in “FDA News Alerts”

Today, the U.S. Food and Drug Administration announced it has awarded 11 new clinical trial research grants, equaling more than $25 million of funding over…

The FDA is announcing an upcoming meeting of its Antimicrobial Drugs Advisory Committee (AMDAC) to discuss Merck and Ridgeback’s Application for the Emergency Use of…

Baltimore, Maryland, October 14, 2021: Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer…

Abbott is recalling Alinity m SARS-CoV-2 and Alinity m Resp-4-Plex AMP Kits because they may cause false positive SARS-CoV-2 results Original source: http://www.fda.gov/medical-devices/medical-device-recalls/abbott-molecular-inc-recalls-alinity-m-sars-cov-2-amp-kit-and-alinity-m-resp-4-plex-amp-kit

FDA Issues Final Guidance to Food Industry for Voluntarily Reducing Sodium in Processed and Packaged Foods Original source: http://www.fda.gov/news-events/press-announcements/improve-nutrition-and-reduce-burden-disease-fda-issues-food-industry-guidance-voluntarily-reducing

The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices. Original source: http://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-risk-infection-when-using-heater-cooler-devices-letter-health-care-providers

The FDA is withdrawing the temporary policies outlined in the guidances for the preparation of certain alcohol-based hand sanitizer products and alcohol for use in…

FDA authorized the marketing of three new tobacco products, marking the first set of electronic nicotine delivery system (ENDS) products ever to be authorized by…

Coronavirus (COVID-19) Update: October 12, 2021 Original source: http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-october-12-2021