Gottlieb wants industry to embrace new R&D initiatives

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 [...]

By | 2019-03-19T05:40:56+00:00 March 19th, 2019|FDA|Comments Off on Gottlieb wants industry to embrace new R&D initiatives

New FDA ‘Request to Connect’ portal goes live

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 [...]

By | 2019-03-15T05:50:32+00:00 March 14th, 2019|FDA|Comments Off on New FDA ‘Request to Connect’ portal goes live

FDA receives comments on its RWE regulatory framework

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 [...]

By | 2019-03-01T05:32:28+00:00 March 1st, 2019|FDA, Legislation|Comments Off on FDA receives comments on its RWE regulatory framework

FDA Launches new pilot project program to track and trace the drug supply chain in the US

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 [...]

By | 2019-02-13T07:10:36+00:00 February 13th, 2019|FDA|Comments Off on FDA Launches new pilot project program to track and trace the drug supply chain in the US

FDA’s Project Facilitate, proposed initiative aims to improve current expanded access framework

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 [...]

By | 2019-01-28T05:34:08+00:00 January 28th, 2019|Expanded Access Programs, FDA|Comments Off on FDA’s Project Facilitate, proposed initiative aims to improve current expanded access framework

FDA releases new strategic Framework for its Real World Evidence Program

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 [...]

By | 2018-12-14T10:17:32+00:00 December 14th, 2018|FDA|Comments Off on FDA releases new strategic Framework for its Real World Evidence Program

FDA releases information on Right to Try on its website

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 [...]

By | 2018-12-05T08:36:22+00:00 December 5th, 2018|Expanded Access Programs, FDA, Legislation|Comments Off on FDA releases information on Right to Try on its website

Meeting held to discuss how to include patient data from web and e-platforms in product innovation and development efforts

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 [...]

By | 2018-11-22T04:20:24+00:00 November 22nd, 2018|FDA|Comments Off on Meeting held to discuss how to include patient data from web and e-platforms in product innovation and development efforts

FDA Making Improvements to Its Expanded Access Program

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 [...]

By | 2018-11-16T06:43:44+00:00 November 16th, 2018|Expanded Access Programs, FDA|Comments Off on FDA Making Improvements to Its Expanded Access Program

FDA to incorporate more of patient experiences and perspective into drug development and review processes

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 [...]

By | 2018-11-09T07:04:43+00:00 November 9th, 2018|FDA, Legislation|Comments Off on FDA to incorporate more of patient experiences and perspective into drug development and review processes