It is the true hybrid of clinical research and clinical care. A way of providing treatment-use or preventative-use access to groups of people in the
Anyone working in medical affairs understands that it’s a highly specialized area. And often, medical affairs executives get so engrossed in their day to day
Project Facilitate, an FDA call center that guides physicians through the process of obtaining expanded access — or compassionate use — to investigational cancer therapies, handled about 161 requests from its launch on June 3 to Aug. 31, an agency spokesperson told BioCentury.
Price controls are the wrong approach; they will stunt drug innovation and restrict patient access to new cures. Reason: Drug development is risky.
Globally there are approximately 7,000 known rare diseases. About 4,000 – 5,000 of those have no available therapies . Consequently, there are many patients with a rare disease who are waiting for a new therapy to become available.
The Biologics Price Competition and Innovation Act (BPCIA), part of the 2010 Affordable Care Act, sought to drive down prices for biologics, much as the 1984 Hatch-Waxman Act did for small-molecule drugs. By allowing manufacturers…
If you’re a drug company developing novel treatment for a serious unsolved disease, you have already been asked: “What’s your strategy for pre-market access?” If
The Expanded Access Summit is about the smart integration of Expanded Access and Named Patient programs into the modern drug development process. The annual leadership