Nidan, Look, Bio. Tred, This notice form the FDA again reiterates that Scott Gottlieb has loosed Janet Woodcock to redesign process and organization to get the 21st CCA advancing drug/device development. No longer will the FDA take in IND's and wait possibly years later for an NDA submission. The FDA will play an aggressive role in matching drug trials to patient needs. Trial design will be a much more collaborative process with the sponsors, scientific community, patient advocates and patients. Trial conduct will be equally collaborative and the approval review will be accelerated because all parties will have been sharing information all along.
What appears to have been an inordinate wait for our Rett Syndrome IND approval will show the wisdom of this new trial process.
Reading the lines and in between the line of this notice, we see that the FDA will no loner play a passive
role in drug development........Scott and Janet want to get safe drugs to those who desperately need them now
-------
"We believe that some of the new organizational structures we’re considering could also allow our review staff to have more time for reviewing and providing feedback to sponsors on clinical protocols. One goal is to engage sponsors earlier in the development process to ensure that trial designs are efficient and structured in the most effective way to identify risks and measure benefit. Equally important, there will also be more ability to engage external stakeholders, such as disease specialists, academic researchers and regulatory partners at other agencies. And with patient-focused drug development becoming a reality, ongoing relationships and interactions with patient groups are becoming an important part of our regulatory practices.
We believe that part of these modernization efforts will be enabled through increased organizational efficiency and possible structural changes that would ultimately flatten the overall matrix of our review process. As part of this effort, for example, we’re considering creating many new therapeutic-specific divisions that’ll have more ability to engage in discrete areas of medicine.
The goal is to make sure that the drug review divisions are therapeutically focused to promote efficient review and provide greater scientific leadership to academic, industry and patient groups. We believe this will deepen internal collaboration and enhance external scientific exchange.
In turn, outside stakeholders and patients, who are focused on specific therapeutic areas, will have more points of contact to the therapeutic areas they’re most focused on. In the past, our structure was organized in a way to match our workload to our different divisions and offices. The goal was to make sure that there was balance across the different offices and divisions. So our organizational structure doesn’t always follow the subdivisions of medicine. That’s why we think these proposals may create a superior structure – one that’s based on the optimal clinical and public health configuration. In turn, we’ll then staff these different divisions in a way that matches our manpower to the flow of applications and critical tasks like post-market safety."
News 
Market Data 
Discover 
