Pearls of Wisdom
Health Research Guidelines Looking to Improve
The Health Improvement Institute has started a project that aims to harmonize health research guidelines. The goal of the project is to eliminate conflicts, overlaps, and gaps that exist within the current health research guidelines. A recent article in...
Congress Attempts to Fix Drug Shortage Issue
A House of Representatives hearing will take place this week about FDA funding. Included in the hearing will be the issue of the current shortages of some life-saving medicines. The number of drugs in short supply in 2011 was 220 which was a substantial increase...
New Medical Device User Fee Program Could Mean $595M in Fees to FDA
Medical device manufacturers could pay up to double in the next 5 years to FDA . In exchange, they hope to see quicker approvals and better communications from FDA. The current program requires about half of that amount and expires September 30, 2012. FDA may bring...
CDRH 2012 Strategic Priorities
FDA’s Center for Devices and Radiological Health (CDRH) recently released its 2012 Strategic Priorities, which includes a number of new initiatives and pilot programs designed to improve regulatory pathways and compliance processes as well as support new device-based...
Hope to Fill the VC Funding Gap for Early Stage Biotechs
Pearl Pathways serves the start up drug and device sector happily. When we work with founders and the small management teams of start ups, it is some of the most rewarding work we do. However, it’s no secret that early stage venture funding for biotechs has fallen...