Section 3309 of the Food and Drug Omnibus Reform Act (FDORA), signed into law on December 29, 2022, amended section 738(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding clause (ii) “Small business fee waiver.” This gives FDA discretion “to waive the ...
This year, we have seen several monumental events that already are, or potentially could be, pivotal to the future of the Laboratory Developed Test (“LDT”) industry – first, the issuance of the U.S. Food & Drug Administration (“FDA” or the “Agency”)final rulein May, which establi...
WASHINGTON-The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter. It’s a move that some advocates have long sought as a way to i...
BY THE END of this week, food additives makers should know where they stand under the new food additives law. Barring last minute holdups, the Food and Drug Administration plans to issue by then the regulations it will use to enforce the law. Last year FDA issued a set of proposed regula...
Medtronic also cited a legal doctrine holding that Congress granted the FDA sole oversight authority over devices receiving premarket approval, which preempts any product defect claims brought under state laws. Manufacturers have drawn on the preemption defense to sidestep liability for patient injuries,...
In the US, the Food and Drug Administration (US FDA) is charged with protecting the safety of food from both pathogens and chemicals used in food production and food packaging. To protect the public in a transparent manner, the FDA needs to have an operational definition of what it considers...
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B)....
The FDA denied a petition from the Natural Resources Defense Council on March 30, which called for a ban on the use of bisphenol A in human food and food packaging. The FDA said further studies or data are needed to influence its assessment an...
“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moder...
Top 10 Most Recalled Food Items & How To Stay Safe The CDC estimates that 48 million people in the U.S. are infected by a food-borne illness every year, and an average of 3000 people even die. These are the top 10 foods most likely to be recalled, according to Consumer Reports. How...