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+00:00 June 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+00:00 June 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+00:00 June 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+00:00 June 12, 2017|General|
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