The CMS/FDA Proposed Parallel Review Process: Can One Clinical Trial Really Satisfy Two Agencies?
by Kelli Hallas | Oct 2011
Readers: After this story was published, FDA and CMS launched a Pilot Program for Parallel Review of Medical Products. Current information can be found on FDA's web site. −Editor Medically necessary vs. safe and effective. Can clinical trials, by design, realistically satisfy the needs ... Read more »
Integrating Internal Strategies to Impact a Successful Product Launch
by Kelli Hallas | Aug 2011
Your company is ISO 13485 certified and has internal processes in place. Individual departments have well-established SOPs. Yes, you have successfully introduced several products to market on a project-by-project basis. If it’s not broken, why fix it? Why the need to integrate strategies? “Stra ... Read more »
by Kelli Hallas | Jun 2011
The product design is flawless. The clinical trial endpoints were met. FDA has given the green light to begin marketing. Manufacturing has ramped up and can accommodate distribution deadlines. The plan is perfect; what could possibly go wrong? Bottom line is this…no matter how unique or innovativ ... Read more »
