Earlier this year, the FDA announced the launch of Project Orbis, a collaborative program which allows for the concurrent submission and review of oncology drugs between partner regulatory agencies. The premise behind such a program [...]
WEP Clinical, the specialist pharmaceutical services company, has announced that it has launched Nitisinone MDK®, in the UK, France, Germany, Italy & Poland. WEP Clinical will make this medicine available on behalf of the [...]
Earlier this month, former FDA Commissioner, Scott Gottlieb, spoke about real-world evidence (RWE) at the Patient-Centered Oncology Care meeting, in Philadelphia, Pennsylvania, saying that the FDA has the money and the mandate from Congress to [...]