Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration ...

Food and Drug Administration commissioner Marty Makary's flagship effort to overhaul how the agency reviews drugs is facing intensifying scrutiny from Congress and the medical establishment over ...

Americans who smoke may soon be hearing a lot more about Zyn, the flavored nicotine pouches that have generated billions in sales while going viral on social media.

Giving final approval to a drug carries significant legal risks, essentially certifying that the medicine meets FDA standards ...

The FDA ImportShield Program centralizes import review, increasing processing speed by 66% and volume capacity by 33%, while ...

FDA delays drug reviews for two priority voucher drugs amid safety and efficacy concerns, extending timelines for Sanofi and Disc Medicine products.

In four months, the program, which aims to modernize how the FDA reviews imported products, increased processing speed by 66% ...

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...

Internal FDA reviews examined in the JAMA study show that the agency repeatedly confirmed that mifepristone is safe. One analysis found that among 1.88 million patients who had used the drug in the US ...

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve ...