The Food and Drug Administration (FDA) is set to pilot test real-time clinical trials in the hopes of expediting results and ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

The FDA proposed Thursday not adding three active ingredients in weight-loss drugs to its so-called bulks list.

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

And FDA explains that they don’t have any extra. Congress has been underfunding FDA for decades, and the agency only stays afloat now by virtue of user fees the industry pays to get submissions ...

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...

Top officials at the US Food and Drug Administration (FDA) say the agency is developing a new, less formal, way for industry to request input on how combination products will be regulated. Combination ...

As noted in Chapter 1, the committee was charged by the Food and Drug Administration (FDA) to review the 510(k) clearance process and answer two principal questions: Does the current 510(k) clearance ...

July 29, 2011 (Washington, DC) — The FDA's 510(k) process for clearing putatively moderate-risk devices has been criticized by some for being too lax and by others for obstructing innovation. Now, a ...

FDA officials want more AI in the review process. The Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in ...

ALBANY, N.Y. & SHANGHAI--(BUSINESS WIRE)--Drug Farm today announced that the U.S. Food and Drug Administration (U.S. Food and Drug Administration, FDA) has accepted DF-003, the company’s ...