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 treatment outside of a clinical trial. Desperately ill patients, family caregivers and treating physicians often consider this option, but navigating [...]

2017-09-08T14:44:01+00:00September 13, 2017|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 physicians, they would participate in a clinical trial. The importance of participation is critical because individuals of different race, ethnicity [...]

2018-05-25T16:30:55+00:00August 4, 2017|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 science, coupled with sound research ethics, is critical to research participants and ultimately, the public. While many in the research [...]

2017-09-13T15:42:27+00:00July 10, 2017|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 medical research to improved coverage for mental illnesses. Some of the highlights of this new law are: Funding for the [...]

2018-05-25T16:30:55+00:00June 12, 2017|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 navigation tools can provide answers. The FDA has an easily accessible, comprehensive expanded access guide for physicians, patients and industry.  [...]

2017-09-13T15:41:08+00:00June 12, 2017|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 it comes to market ensures that all marketed medicines meet important standards for patient safety and drug effectiveness. Below is [...]

2018-05-25T16:30:55+00:00June 12, 2017|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. As in its regulation of drugs, the FDA’s approval process for medical devices is designed to ensure the safety of [...]

2017-09-13T15:40:00+00:00June 12, 2017|General|
Load More Posts