Pearls of Wisdom
The Value of a Second Opinion
If you visit a doctor and receive a diagnosis stating that you require major surgery, would you just accept that and get on with the procedure? Or, would you seek a second opinion before going under the knife? Second opinions can be just as important in the regulatory...
Adoption of eConsent: When will it begin?
Rapid development of technology in the medical industry is forcing life science companies and research institutions to review and modify internal procedures to adapt. Electronic informed consent (eConsent), though still highly debated, is a prominent example of a...
Don’t Whine about FDA: How to Talk so Regulators Will Listen
Robert Seevers, Ph.D., Senior Advisor at Pearl Pathways, will discuss the right way to talk to FDA this Thursday, February 7, 2019 at a VisionTech Partners event. The event will take place from 5:30 - 7:30p PM EST at Leaf Software in Carmel, Indiana. Register for the...
FDA proposes sweeping changes for the 510(k) process. What does it all mean?
In a press release issued on November 26, 2018, the U.S. Food and Drug Administration (FDA) announced more details regarding an initiative to improve the 510(k) process. The modernization plan was previously announced as part of FDA's Medical Device Safety Action...
The world’s first gene-edited babies – 8 days after the claim
In the latest example of regulations not keeping up with technology, on November 25, 2018, Marilynn Marchione of the AP published a report regarding He Jiankui’s claim that he had helped create the world’s first gene-edited babies using CRISPR-Cas9...