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 [...]
Real World Data (RWD) is health data collected from outside the tightly controlled clinical trial setting. It provides greater insight into experiences with pharmaceutical products and devices at all stages, from research and development, to [...]
The goal of the FDA is to ensure that patients can access needed medicines in a safe and compliant manner, and the agency will support any legislation that aims to further this. As such, although [...]
Under new legislation in the US, the 21st Century Cures Act, the FDA has been charged with incorporating more of the patient perspective into the development and review processes for new drugs and medical devices. As part [...]
Earlier this year, federal Right to Try legislation was signed into law by President Trump. This law allows patients to request access to investigational drugs outside of the clinical trial setting. However, even before this [...]