For instance, "the backlog of FOIAs ... is enormous," he said. Califf said the FDA has far greater opportunities for improved ...

It’s a long and arduous process that requires tons of data. Plus, the agency wants to rebuild trust after coming under attack during the Trump Administration. While nearly 190 million Americans ...

Here’s a step-by-step breakdown of how a drug earns FDA approval. 1. Preclinical phase. Before a drug company can test an experimental treatment on humans, it must prove the drug is safe and ...

Currently, no coronavirus vaccine is fully approved by the FDA, but three were given emergency use authorization by the agency. Stream NBC 5 for free, 24/7, wherever you are. WATCH HERE ...

So that’s the path to emergency authorization, which Pfizer received in December. Since then, per the standard FDA approval process, the drug maker has kept track of any serious side effects ...

The process and speed in which it takes to develop drugs is also dependent upon the FDA. Currently, it takes 12 years and $2.9 billion to bring a drug from lab to patients. The antiquated FDA drug ...

This new Shingrix vaccine presentation eliminates the need for reconstitution, simplifying the administration process for ...

Dr. Bob Newman, a University of Virginia Medical School graduate and U.S. Navy veteran, spent more than 15 years in private practice in rural Virginia and 20 years teaching family medicine. He teac… ...

FDA Commissioner Hahn said the new policies would help address "urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing ...

Gilead Sciences' hepatitis C drug is racking up record-setting sales. Vertex Pharmaceuticals' drug is the first to treat an underlying cause of cystic fibrosis. The newest drug from Pharmacyclics ...