Last week both CDER and CDRH released a list of guidance documents they intend to develop or finalize over the next year. However, it is interesting to note that the approach and information provided by each FDA center diverged significantly. CDRH provided details as to the priority of guidances they plan on developing, offered specific metrics they will use to measure success, and opened up a docket to receive stakeholder comments. CDER also provided a list of guidances; however the process to administer comments and specificity on what guidance documents would be prioritized was lacking.
A. CDRH creates an advantage for industry who work with their center
There is a great advantage for industry members who primarily work with CDRH to develop their product lines, given that the center has provided clarity as to the methodology of guidance development and has provided a pathway to get involved earlier in the process.
For an example, CDRH divided their guidance list into two groups, an A list of top priority guidances and a B list for guidances to be developed, resource permitting. A docket was opened to allow stakeholders to comment on the guidances on day one. CDRH committed to metrics for finalizing guidance documents and specifically sought input on older ones issued in 1985, 1995, and 2005. Finally, they requested input on three specific guidances being Framework for Patient Matched Instrumentation for Orthopedics, Medical Devices Intended for Aesthetic Use, and Dual 510(K) and Clinical Laboratory Improvements Amendments (CLIA) Waiver by Application which are in the early stage of development.
With these specifics mentioned, it is to industry’s advantage to get involved as soon as possible so that their specific matters dealing with their respective product types are addressed.
B. CDER did not meet the bar set by CDRH
Unfortunately, this clarity has not been provided by CDER and it is urged that industry members who deal with this center make it apparent. Even though CDER released their list of guidance documents, they failed to distinguish between finalizing draft guidance’s and publishing new draft guidances documents. They did not indicate which topics were priorities and even failed to open a docket to allow stakeholders to comment on the topics that should be addressed.
C. Recommendations for Industry dealing with CDER
We recommend that when manufacturers are negotiating PDUFA, they may want to mirror CDRH’s processes. We also recommend that CDER go beyond the bar set by CDRH in that they create more robust goals, such as providing a confirmatory list of guidance documents that CDER will complete, and require a frequent review of guidances on an on-going basis to ensure that outdated guidances are made void. Finally, the list of guidance documents should be accompanied with a description of the scope of the guidance, questions it intends to answer and issues it will address.
Providing clarity to industry at the forefront on guidance development will increase transparency and allow innovation to move forward more efficiently. Thus, it would be helpful for CDER to release more detailed information into their guidance development so that industry can be prepared to respond and plan accordingly.