Blog

What is expanded access and how can a desperately ill patient find treatment through this process? Are there online tools available for navigating the steps needed?

Expanded access, also known as compassionate use, is a process by which a patient can petition both the maker of an experimental treatment and the US Food and Drug Administration for access to the treatment [...]

September 22, 2017|Categories: General|

How many drugs provided through expanded access actually get marketing approval from the FDA?

A new study from Bioethics International shows that a majority of drugs provided to very ill patients via the Food and Drug Administration's (FDA) expanded access program - 76% - eventually gain marketing approval from [...]

September 19, 2017|Categories: General|

Leading cancer organizations have formed a coalition and provided recommendations to extend better care to minorities. What do they suggest?

A summit attended by healthcare experts and representatives from the National Institutes of Health (NIH), American Cancer Society, the American Society for Cancer Research (ASCR), and American Society of Clinical Oncology (ASCO) convened, producing a [...]

September 15, 2017|Categories: General|

The Reagan-Udall Foundation Navigator: An Online Tool to Help Desperately Ill Patients Considering Compassionate Use Treatment Options

Expanded access, also known as compassionate use, is a process by which a patient can request both the manufacturer of an experimental product (treatment) and the US Food and Drug Administration for access to the [...]

September 13, 2017|Categories: General|

Diversity in Clinical Trials—History and Barriers

A 2015 study demonstrates a continuing, significant lack of participation among minorities in clinical trials in the US. This is the case even though more than 70% of Americans stated that, if advised by their [...]

August 4, 2017|Categories: General|

Research Ethics Education: A Critical Need

Good science is based on sound research design and ethical basis, competent researchers and high quality, transparent and reproducible data. With the significant and swiftly occurring advances being made in technology, science and medicine, good [...]

July 10, 2017|Categories: General|

21st Century Cures Act – What is to Come?

Since the passage of the 21ct Century Cures Act in December, many have asked what it  means to the average citizen. This sweeping legislation promises to improve upon a range of issues from high-risk, high-reward [...]

June 12, 2017|Categories: General|

Expanded Access (Compassionate Use) Information Navigation: Finding the Best Tools

Information can be a patient and physician’s best ally, particularly when considering expanded access options. It can be challenging to find the appropriate resources when urgency from an illness or disease influences decision making. Trusted [...]

June 12, 2017|Categories: General|

The Drug Development and Approval Process

Drug development and approval  sometimes seem like a mysterious process to a patient, caregiver or treating physician. Though complex and time consuming, the Food and Drug Administration (FDA) process to approve a new drug before [...]

June 12, 2017|Categories: General|

FDA Medical Device Approval Process

When some consumers think about the Food and Drug Administration (FDA), approval of drugs most often comes to mind, but approval and regulation of medical devices is an equally important responsibility of this federal agency. [...]

June 12, 2017|Categories: General|