New Dark Report Webinar: FDA Prepares to Regulate LDTs — What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now
Our distinguished panel explains how the FDA’s
draft guidanceis a road map that labs
can follow immediately to optimize how
the FDA treats their most important LDTs
There’s big news ahead if your lab performs laboratory-developed tests (LDTs)! On July 31, the Food and Drug Administration sent its 60-day notice to Congress that it is moving forward to regulate LDTs. The clock is now ticking down the minutes until your lab will need to comply with a host of new requirements.
But, will your lab be ready? Is the right strategy to simply sit back and wait for the FDA to put the guidelines in place? Or, will it benefit your lab greatly to understand what is already known about the FDA’s plans—and use that knowledge to get a head start on packaging your lab’s LDTs to obtain speedy FDA clearance ahead of hundreds of other labs?
Failure to answer these questions correctly can spell disruption in your lab’s delivery of LDT test results to clients—not to mention triggering financial chaos and subjecting your lab to enforcement action by this very powerful federal agency. To help you at this critical moment, we are offering an exceptional learning event, “FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now” on Wednesday, September 17, 2014 at 1:00 PM EDT.
What will add extra value to this webinar
is the informationthat your presenters
will share with you about these specific issues:
- Why your lab shouldn’t wait, but will benefit from decisive action now
- Whether private payers will require FDA clearance of your LDTs before issuing coverage and reimbursement determinations
- How much of its existing steps for medical device review the FDA will incorporate into its LDT review requirements
- Developing the business case for LDT clearance with your lab’s owners and investors
- Addressing the cost of LDT compliance
- Timing of getting your LDT tests to market
Where else can you get all this information, in one place and at one time? Given the importance of LDTs to your lab, this is a “must-attend” session.
You’ll hear from a panel of consulting and legal veterans who are already up to speed with the FDA’s draft guidance that it delivered to Congress on July 31, at the same time that it notified lawmakers that it intended to regulate LDTs.
- First up will be Jane Pine Wood….
- Next is Kuo Tong…
- Pulling it all together as presenter and moderator of the live
question and answer session is Rick Cooper…