Amgen’s Prolia Complete Response submission: FDA classifies and units PDUFA date Amgen Inc generic medication more info . today announced that the U.S. With the Class 2 designation, the FDA established a corresponding Prescription Drug User Fee Act action time of July 25, 2010. Related StoriesElderly ladies should take more supplement D supplementation through the wintertime, suggests researchersNew proteins supplement lowers cholesterol, prevents osteoporosisDiet rich in soy proteins and isoflavones can protect menopausal ladies from osteoporosisIn October 2009, the FDA’s Division of Reproductive and Urologic Items issued a Full Response Letter for the Biologic License Program for Prolia in the procedure and avoidance of postmenopausal osteoporosis.
Amicus brief filed against tobacco companies’ lawsuit challenging FDA tobacco regulation law Today, eleven open public health and consumer advocacy companies filed a friend of the courtroom short asking a federal court to reject a lawsuit by R.J. Reynolds, Lorillard and additional tobacco companies that seeks to block key provisions of the new federal laws regulating tobacco products. The immediate issue prior to the court is the industry’s challenge of a provision that requires FDA acceptance before tobacco companies can make claims about ‘altered risk tobacco products.’ The tobacco companies also have challenged other marketing restrictions in the Family Smoking Prevention and Tobacco Control Act, which authorizes the U.S. Food and Drug Administration to regulate the manufacturing, marketing and sale of tobacco products.