FDA approves a Heron Therapeutics NDA for Aponvie (aprepitant) injectable emulsion, indicated for preventing postoperative nausea and vomiting in adul...
Federal Register notice: FDA releases a final guidance entitled Q3D(R2) Guideline for Elemental Impurities.
CDRH updates a 4/27 letter to health care providers to ensure those in operating room settings are aware of a Medtronic recall of endotracheal tubes.
HHS details specific FDA projects that will be undertaken as part of President Bidens recent Executive Order launching a National Biotechnology and Bi...
Federal Register notices: FDA publishes three notices about its most recent periodic reassessment of the definition of small number of animals for min...
Federal Register notice: FDA determines that intramuscular antibiotic bacitracin for injection, 10,000 units/vial and 50,000 units/vial, was withdrawn...
Akorn pays $7.9 million to resolve allegations that it caused Medicare to submit false claims by delaying an Rx to OTC switch for three generic drugs.
A MasterControl white paper lists the processes involved in the most common FDA medical device observations and Warning Letters.
