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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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. [...]