So the FDA should be more lax on requirements for approval?
Should they reduce the Preclicnal PharmTox requirements? How long should a cancer trial take if it has 500 brain cancer patents to enroll and it measures improvements in survival that takes over a year? Should Pharma just one study or should they do a coulple of serially run clinical studies to understand the toxicities and how the drug works best? I'd love for development timelines to be quicker, but I need a Gantt chart to better understand where the time savings would come from without compromising the safety and data supporting efficacy. Help me understand.
Also.
Most substantial patents are filed way before the approval of the drug. Rarely if ever has a drug had, for example, a composition of matter patent for 20 years after approval-- even with the extensions for regulatory delay that the USPTO allows. Not to say that Pharma don't extensively engage in product life-cycle management, sometimes very questionably extending exclusivity of products, and that is something that should be addressed.
Also. Most substantial patents are filed way before the approval of the drug. Rarely if ever has a drug had, for example, a composition of matter patent for 20 years after approval-- even with the extensions for regulatory delay that the USPTO allows. Not to say that Pharma don't extensively engage in product life-cycle management, sometimes very questionably extending exclusivity of products, and that is something that should be addressed.