The Food and Drug Administration is advising consumers not to purchase or use Genergy, a product promoted and sold as an energy booster on the website http://www.amazon.com and possibly in some retail stores.

The Food and Drug Administration is advising consumers not to purchase or use Round 2, a product promoted and sold as a strength, energy, and endurance booster on various websites, including http://www.amazon.com,…

The Food and Drug Administration is advising consumers not to purchase or use Mens Maximum Energy Supplement, a product promoted and sold as an energy booster on the website http://www.amazon.com and possibly in some retail stores.

The Food and Drug Administration is advising consumers not to purchase or use BIG GUYS Male Energy Supplement, a product promoted and sold as an energy booster on the website http://www.amazon.com and possibly in some retail stores.

The Food and Drug Administration is advising consumers not to purchase or use The Rock, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores. This product…

W.W. Industrial Group, Inc., NY is recalling Parashore Pear Slices in juice, 15 oz, because they have the potential to be contaminated with elevated levels of lead and cadmium.

FDA Commissioner’s National Priority Voucher Program. The Commissioner’s National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.

This new pilot program is designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans.

Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

CBER’s international activities can be categorized in the following functional areas: regulatory harmonization, regulatory capacity building, information sharing, international standards setting, and collaborative research.