The FDA released an action plan to further define the regulatory framework surrounding the use of artificial intelligence (AI) and machine learning (ML) in medical devices. Here are the key takeaways.
The first at-home collection kit has been approved…but there’s a catch
This morning, the FDA announced that they approved the first COVID-19 test with an at-home collection option.This move reverses the clarification that the FDA's March...
Learn what the Health and Human Services announcement means for licensed pharmacists and the PREP Act.
A primary component of the Health and Human Services fight against the COVID-19 pandemic is widening the availability to testing. On April 8th, they recognized...
Since the Innovation Pathway program initiated in 2011, the Food and Drug Administration (FDA) has provided means to expedite its review process for groundbreaking products. While critics question how faster review cycles impact patient safety, one thing is clear…products approved under priority review suffer more quality issues.
More on that later. The latest incarnation of a priority review track is the Breakthrough Devices Program, the spiritual successor to the Expedited Access Pathway...