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Project Orbis: new collaborative program allows for concurrent drug approvals in participating countries

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 [...]

By Yasmin Khera|2019-11-28T16:24:34+00:00November 28th, 2019|FDA|
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WEP CLINICAL LAUNCHES NITISINONE MDK IN THE EU ON BEHALF OF MENDELIKABS INC.

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 [...]

By Yasmin Khera|2019-12-03T10:15:52+00:00November 28th, 2019|Blog|
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Former Commissioner says FDA has money and mandate to accelerate use of RWE in drug approval process

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 [...]

By Yasmin Khera|2019-11-21T10:52:27+00:00November 21st, 2019|FDA, Real World Data - Case Studies|
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