New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers

Huntsville, Texas — StuffbyNainax LLC is voluntarily recalling all lots of MR.7 SUPER 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil, which are active ingredients in FDA-approved prescription drugs used to treat male erectile dys

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco

Quesito El Establo of Salem, NH is recalling all Spanish Cheese (Quesito Colombiano) manufactured in their facility, due to the presence of rodent, rodent activity, and other insanitary conditions during the manufacturing and storage process.

Therefore, in order to ensure that batches of imported heparin continue to meet regulatory standards, FDA is requiring that all lots of Heparin Sodium be required to be in compliance with latest USP specifications.

PDUFA and BsUFA Quarterly Hiring Updates

Olympus is removing certain High Flow Insufflation Unit models due to software issues that may lead to overpressure events.