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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

Why might companies refuse to provide pre-approval drug access

After Right to Try legislation was passed in the US earlier this year, many believe that desperate patients will now find it easier to try investigational products outside of the clinical trial setting. However, like with the FDA’s Expanded Access Program, the Right to Try law does not require companies to provide their unapproved drugs [...]

By | 2018-11-30T05:11:46+00:00 November 30th, 2018|Expanded Access Programs, Legislation|Comments Off on Why might companies refuse to provide pre-approval drug access

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

FDA proposes international standardization for generic drug development and approval

In the US, prescription drug prices are continuing to increase. In response to this, the FDA has come up with new initiatives to improve generic drug development and access. Generic drugs are cheaper alternatives to brand-named products, which increase competition on the market place. Although the FDA does not play a direct role in setting [...]

By | 2018-10-31T06:22:29+00:00 October 31st, 2018|FDA, Reference Listed Drug|Comments Off on FDA proposes international standardization for generic drug development and approval

MHRA publishes proposals for dealing with a no-deal Brexit

In the last remaining months leading up to the UK’s exit from the EU, the Medicines and Healthcare products Regulatory Agency (MHRA) is taking action to prepare for a potential ‘no-deal’ Brexit. The MHRA strongly believes that cooperation between the UK and the EU will be beneficial for both sides and remains hopeful that an [...]

By | 2018-10-09T11:36:27+00:00 October 9th, 2018|Governments, Health|Comments Off on MHRA publishes proposals for dealing with a no-deal Brexit