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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

Pharma companies encouraged to prepare for ‘no-deal’ Brexit

With the Brexit leave date fast approaching, efforts are continuously being made to ensure that patient health and wellbeing remain protected, following the UK’s exit from the EU. Last month, the Secretary of State for Health and Social Care, Matt Hancock, released two letters to the pharmaceutical industry outlining recommended contingency plans for a potential ‘no-deal’ Brexit [...]

By | 2018-09-19T08:56:28+00:00 September 19th, 2018|Health, Legislation|Comments Off on Pharma companies encouraged to prepare for ‘no-deal’ Brexit

Healthcare organizations come together to create new generic drug company

Medicine shortages and rising drug prices continue to plague the US healthcare system, despite efforts being made by government on the national and local level to combat the issue. As it stands, hospitals around the country are finding that they cannot access the products they need and are being forced to bear the brunt of [...]

By | 2018-09-12T08:21:00+00:00 September 12th, 2018|Health, Reference Listed Drug|Comments Off on Healthcare organizations come together to create new generic drug company