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FDA suggests avoiding double blind, randomized clinical trials using a placebo for certain types of development programs

Last month, the FDA released a draft guidance document suggesting investigators should stop using double blind, randomized clinical trials with placebo products, when developing treatments for certain malignant hematologic and oncologic diseases. In the three-page document, the agency explains the rationale behind this suggestion and proposes some alternative trial designs. Interested parties now have 60 [...]

By | 2018-09-05T08:46:30+00:00 September 5th, 2018|FDA, Reference Listed Drug|Comments Off on FDA suggests avoiding double blind, randomized clinical trials using a placebo for certain types of development programs

FDA initiates complex innovative trial designs (CID) pilot program

The FDA has recently initiated a pilot program which will help drug manufacturers use complex innovative trial designs (CID). This move comes after the agency committed to helping facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs, as part of the sixth iteration of the Prescription Drug User Fee [...]

By | 2018-08-31T10:54:23+00:00 August 31st, 2018|Drug Manufacturers, FDA|Comments Off on FDA initiates complex innovative trial designs (CID) pilot program

Senate goes against White House by proposing $2 billion increase in funding for NIH

In a move that defies President Trump’s proposed budget for fiscal 2019, the Senate is gearing up to approve a $2 billion increase in funding for the National Institutes of Health (NIH). This increase has been proposed as part of the Senate’s “minibus”, which combines the Senate’s Defense bill and its Labor, Education and Health [...]

By | 2018-08-23T06:38:28+00:00 August 23rd, 2018|Health, Legislation|Comments Off on Senate goes against White House by proposing $2 billion increase in funding for NIH

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 releases Biosimilars Action Plan

The US has had a hard time accepting biosimilar drugs, the copycat versions of biologics which are similar to the innovator product, but not exact replicas. To date, the FDA has approved only 11 biosimilar products, while the EMA has approved 25. Furthermore, of the 11 products that have been approved, 8 have been kept [...]

By | 2018-08-02T06:01:37+00:00 August 2nd, 2018|FDA, Reference Listed Drug|Comments Off on FDA releases Biosimilars Action Plan

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)