The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...

After the FDA canceled a key advisory meeting, government doctors stepped in to propose a trivalent flu vaccine for the ...

The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...

The FDA has developed draft guidance addressing confusion and legal action over the naming and labeling of plant-based alternatives to eggs, ...

The Food and Drug Administration has increased the risk level of two coffee creamers recalled in late February.

Pharmaceutical consultants apply their comprehensive expertise in different areas to accelerate the drug development process.

A new bill would, if passed, force businesses that sell vaping products to have guidelines and regulations about what can be ...

It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...

We've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...