Tag: FDA

"The Senate... must reject Califf's nomination and demand that Biden nominate an individual who has been dedicated to advancing public health."

The consulting giant was helping Purdue Pharma and Johnson & Johnson fend off FDA regulations even as it helped shape FDA drug policy.

Dosing puppies with drugs designed for humans won’t make people safer. In fact, it poses serious risks to human health.

New information from the Indian Health Service calls into question why the agency purchased expensive medical gear that it now cannot use as intended.

"FDA has tools that could mitigate opioid risks more effectively if the agency would be more assertive in using its power to control opioid prescribing, manufacturing, and distribution."

Unfortunately for those who turn to generics to save money, the FDA relies heavily on the honor system with foreign manufacturers, and U.S. consumers get burned.

A report by the Environmental Working Group reveals that an estimated 2,000 untested chemicals, several of them known or suspected carcinogens, are legally present in conventional packaged foods sold in U.S. supermarkets. But this major public health concern is largely unrecognized by the Food and Drug Administration, which operates under a policy on food additives dating back to 1958.

The FDA plans to require pre-market safety assessments for gene-edited food animals, as they do for new animal drugs.

"FDA will be working with Johnson & Johnson to facilitate further investigation to substantiate that the product is authentic."

"We also believe that FDA’s responsibility to American patients includes a responsibility to be transparent when possible, a commitment that has not been fulfilled in this case.”