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 May 2017, Gottlieb has been praised for the work he has done to modernize R&D processes and streamline guidelines for [...]
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 support groups, advocates and caregivers, and health care professionals and organizations to submit questions about drugs and medical devices and/or [...]
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 with this, late last year, the FDA released a 40-page regulatory framework outlining how the agency plans to utilize RWE [...]
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 enacted by Congress in 2013, aims to better protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs. Under this [...]
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 program, which has been dubbed Project Facilitate, will see the FDA taking on a more involved role, helping drive the [...]
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 testing and regulatory review, right through to commercialization and market use. This raw data can be collected from a variety [...]
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 the FDA was opposed to Right to Try prior to its passage earlier this year, now that it has been signed [...]
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 of this, last week, the Patient Engagement Advisory Committee to the FDA held a public meeting to discuss the topic [...]
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 law was passed, patients had the option to try promising new therapies, prior to approval, through the FDA’s Expanded Access [...]
Over the past decade, regulators and healthcare authorities have become increasingly aware of the important role that patients can play in developing new medicines and getting them to market. In light of this, in new legislation in the US, the 21st Century Cures Act, which was passed in December 2016, the FDA has been charged [...]