A seasoned FDA compliance and regulations expert says you can watch for these major ways health intelligence may change for ...
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
While sleep supplements can be beneficial, the lack of regulation means consumers are not assured of a safe and effective ...
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical ...
A weight loss supplement has been given the FDA's highest recall classification after being pulled from shelves in December.
and we will continue to follow and comply with FDA’s guidance and safety standards." The petition to remove Red No. 3 from foods, supplements and medications was presented in 2022 by the Center ...
The second bans dye Red No. 3—also known as erythrosine, a color additive made from petroleum—from foods, dietary supplements ... follow and comply with FDA’s guidance and safety standards.” ...