The FDA published their complete response letters to drug and biological product applications as part of an effort for more transparency.

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

Amphix Bio, a company spun out from Stupp’s Northwestern laboratory, is helping navigate the FDA approval process and has received early feedback from the agency on the drug development program for ...

The FDA proposes to revoke standards for 18 dairy products, including low-sodium cheddar and colby cheese, acidified milk and ...

For decades, above-the-knee amputees have had to live with stiff, uncomfortable prosthetics that felt more like rigid tools ...