"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more
4/13/2018
/ Biopharmaceutical ,
Clinical Trials ,
Expanded Access Programs (EAPs) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Preemption ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Oversight ,
Right to Try ,
Terminal Illness Treatments
To prevail in a product-hopping case, a plaintiff must be prepared to establish both monopoly power and anticompetitive effects.
On September 28, a unanimous panel of the U.S. Court of Appeals for the Third Circuit...more
10/6/2016
/ Anti-Competitive ,
Appeals ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Hopping ,
Sherman Act ,
Summary Judgment ,
Warner Chilcott