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 [...]
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 [...]
Last week, the National Organization for Rare Disorders (NORD) held its annual summit in Washington DC. This meeting brings together stakeholders from across the rare disease space in order to foster continued learning, communication, and [...]
As part of the 21st Century Cures Act, the FDA has been charged with creating one or more guidance documents regarding the collection of patient experience data. Patient experience data is information collected on the [...]
The FDA recognizes the important role that Real World Evidence (RWE) can play in the drug review process and has been making efforts to encourage its use in certain submissions made to the agency. RWE [...]
The FDA is planning to launch a new program later this year which will streamline the expanded access application and review processes, so that patients can more readily receive access to promising investigational therapies. The [...]
Earlier this month, Scott Gottlieb, announced that he will be stepping down from his post as FDA Commissioner to spend more time with his family. Although he has had a relatively short term, serving since [...]
Last week, the FDA launched its new ‘Request to Connect’ portal, an initiative developed by the agency to encourage greater understanding of, and participation in, the FDA's regulatory work. The online portal invites patients, their [...]
The FDA has recognized the important role that real-world evidence (RWE), i.e. evidence that is collected outside the tightly controlled clinical trial setting, can play in furthering drug development and facilitating drug approvals. In line [...]
As required under the Drug Supply Chain Security Act (DSCSA), the FDA has recently launched a new pilot project program to track and trace the drug supply chain in the US. The DSCSA, which was [...]