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

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

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

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