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

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 policy on EAP adverse event reporting

For patients with rare, life-threatening diseases, there often isn’t the option to wait for promising new medicines to come to market. Clinical trials allow these patients to try investigational drugs while they are still in development, however, not all patients will be able to enroll in active clinical trials. To support these excluded patients, companies [...]

By | 2018-08-10T04:48:16+00:00 July 16th, 2018|Expanded Access Programs, FDA|Comments Off on FDA policy on EAP adverse event reporting

Who is in charge of granting pre-approval drug access?

Patients suffering from rare diseases or life-threatening illnesses, like cancer, can often find that there are very few treatment options available to them. For these patients, accessing an investigational drug outside of the clinical trial setting could be the only viable option. Governments and health agencies across the world recognize the importance of providing pre-approval [...]

By | 2018-08-10T04:52:35+00:00 July 4th, 2018|Expanded Access Programs, Unlicensed Medicine Access|Comments Off on Who is in charge of granting pre-approval drug access?

What patients are eligible for pre-approval drug access?

Recently approved legislation, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017”, allows patients in the US the ability to request access to investigational drugs, without any approval or oversight from the FDA. This Right to Try law was passed in an attempt to improve upon the prior system [...]

By | 2018-08-10T04:54:47+00:00 June 27th, 2018|Expanded Access Programs, FDA|Comments Off on What patients are eligible for pre-approval drug access?

Why collect Real World Data (RWD)

Randomized controlled trials (RCTs) have long served as the gold standard for developing and assessing new drugs and devices. However, over the past couple of years, there has been a real push towards collecting and using Real World Data (RWD), rather than focusing solely on the standardized clinical trial method. RWD is any information relating [...]

By | 2018-08-10T04:56:32+00:00 June 15th, 2018|Expanded Access Programs|Comments Off on Why collect Real World Data (RWD)

FDA commissioner releases statement on Right to Try

The national Right to Try bill was signed into law last month by President Donald Trump. The legislation intends to allow patients with no other treatment options available to them to try investigational drugs that have passed basic safety and efficacy studies, without requesting permission from the FDA. This offers an alternative pathway to the [...]

By | 2018-08-10T05:02:58+00:00 June 7th, 2018|Expanded Access Programs, FDA, Legislation|Comments Off on FDA commissioner releases statement on Right to Try

Right to Try becomes law

On Wednesday of this week, President Donald Trump signed the national Right to Try bill into law. The Senate version of the bill was cleared by the House earlier this month, after much debate and deliberation. Once it takes effect, the law promises to improve treatment access for patients across the US who cannot wait [...]

By | 2018-08-10T05:11:48+00:00 May 31st, 2018|Expanded Access Programs, Legislation|Comments Off on Right to Try becomes law

Letter sent to Congress opposing Right to Try

The Right to Try movement in the US has been gathering momentum in the past year. Currently, 38 US states have enacted Right to Try legislation, and national-level legislation is now being considered by Congress, after being passed by Senate last August.    However, there are some who are trying to prevent the spread of [...]

By | 2018-03-07T11:41:15+00:00 February 6th, 2018|Expanded Access Programs, Legislation|Comments Off on Letter sent to Congress opposing Right to Try