FDA Issued To Final Rules For Premarket Review of New Tobacco Products


CITY OF WASHINGTON (October 4, 2021)---Today, the U.S. Food and Drug Administration issued two final rules for the premarket review of new tobacco products. These foundational rules provide additional information on the requirements for the content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of the…

FDA Cleared First New Major Technological Improvement for CT Imaging


CITY OF WASHINGTON (September 30, 2021)--Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. “Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or…

Public Health Experts ‘Flabbergasted’ That Biden Hasn’t Picked An FDA Chief Leaving Scientist To Lead The Administration


President Joe Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the election, has flummoxed public health experts who say it’s baffling for the agency to be without a permanent leader during a national health crisis. The pandemic has taxed the FDA,…

PFIZER AND BIONTECH ANNOUNCE POSITIVE TOPLINE RESULTS FROM PIVOTAL TRIAL OF COVID-19 VACCINE IN CHILDREN 5 TO 11 YEARS


NEW YORK AND MAINZ, Germany--(September 20. 2020)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered…

FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals


CITY OF WASHINGTON (August 13, 2021)---Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who…

DSD Merchandisers, Inc. Issues Allergy Alert on Undeclared Peanuts in Dark Chocolate Malt Balls 9oz Tub


CITY OF WASHINGTON (August 5, 2021)---DSD Merchandisers, Inc. of Livermore, CA is recalling 252 individual 9 oz. Deli tubs of Dark Chocolate Malt Balls because it may contain undeclared Peanuts. People who have an allergy or severe sensitivity to Peanuts run the risk of serious or life-threatening allergic reaction if they consume these products. Dark Chocolate…

Sunshine Mills, Inc. Issues Voluntary Recall of Certain Products Due to Potentially Elevated Levels of Aflatoxin


Sunshine Mills, Inc. is issuing a voluntary recall of certain products due to potentially elevated levels of Aflatoxin above the acceptable limit. Aflatoxin is a naturally occurring by-product from the growth of Aspergillus flavus and can be harmful to pets if consumed in significant quantities. No illnesses have been reported in association…

FDA Warns Consumers To Avoid Certain Products With Hiden and Potentially Dangerous Drug Ingredients


CITY OF WASHINGTON (July 30, 3031)---the FDA  issued a letter to notify Amazon about its distribution of certain products with hidden and potentially dangerous drug ingredients represented as conventional foods or dietary supplements for weight loss, body building, pain relief, sleep aids, and sexual enhancement.  The agency wrote an untiled…