About Gerrod McDonald

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So far Gerrod McDonald has created 13 blog entries.

FDA’s Competitive Generic Therapy (CGT) designation

Earlier this week, the FDA approved potassium chloride oral solution which is the first generic drug to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway has been created as part of the FDA’s broader Drug Competition Action Plan. The agency recognizes the important role generic drugs can play in increasing competition and [...]

By | 2018-08-10T09:30:44+00:00 August 10th, 2018|FDA, Reference Listed Drug|Comments Off on FDA’s Competitive Generic Therapy (CGT) designation

FDA real world data enterprise proposal

‘Real world data’ is becoming increasingly important when it comes to developing and reviewing promising new medicines. As this data is collected from a variety of sources outside the narrow, tightly controlled clinical trial setting, real world data provides a broader insight into how a new drug will work in the larger patient population. Once [...]

By | 2018-08-10T04:45:45+00:00 July 19th, 2018|FDA|Comments Off on FDA real world data enterprise proposal

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

NORD launches new patient initiative, RareInsights

Late last month, The National Organization for Rare Disorders (NORD) launched its new initiative, RareInsights, aimed at expanding public knowledge of rare diseases and using that knowledge to create real-world solutions for patients. NORD is one of the US’ leading non-profit organizations advocating for rare disease patients through education, funding and support for drug research [...]

By | 2018-08-10T05:07:01+00:00 June 6th, 2018|Health|Comments Off on NORD launches new patient initiative, RareInsights

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

Study conducted to examine how to broaden clinical trial eligibility criteria

National Right to Try legislation was passed by Congress last week in an effort to make investigational drugs more readily available to patients who have no other treatment options available to them. However, many believe this legislation will do little to help patients and have argued that regulators should focus less on passing new laws [...]

By | 2018-08-10T05:27:59+00:00 May 25th, 2018|FDA|Comments Off on Study conducted to examine how to broaden clinical trial eligibility criteria