Some of the afternoon sessions at AAM shone the light on approaching development of complex drug products including drug/device, topicals, ophthalmic products, and orally inhaled products. Each session provided a treasure trove of information regarding the specific dosage forms and issues that the agency and industry has had to deal with. To cover it all is too much information for a blog post so let me hit the general recommendations for a successful submission and hopefully an approval.
- Approach the Agency early in the game by requesting a pre-ANDA or development meeting. Firms should begin well before any potential projected submission date and provide the Agency with a detailed plan for development.
- Be certain to identify issues related to characterization and make that part of the initial meeting with OGD.
- Know the reference listed drug (RLD). In other words, do your homework thoroughly on characterizing the critical aspect of the RLD. Remember that there is likely to be batch-to-batch variation in the RLD so be sure to select numerous different lots of product to assure you can see the appropriate batch-to-batch variation.
- Be certain to read all product-specific bioequivalence recommendations and guidance documents related to the specific dosage form for which you are seeking approval.
The specific break out sessions gave specifics on each type of complex product and provided case studies where appropriate.
The session on Post Approval Changes presented by Scott Tomsky of Teva provided some interesting recommendations for FDA regarding clarification of certain issues regarding PAS supplement and changes to an approved application. Scott also praised OGD and OPQ for the handling of supplements, calling the group one of the shining stars of the generics program indicating they routinely beat GDUFA goal dates and, for application changes for drug shortage issues, they turn around the approvals very quickly, sometimes in a matter of days. In addition, providing approval letters by email has improved the ability to implement approved changes faster. Scott also spoke of outdated guidance documents being cited in newer guidances and the need to clean up the inconsistencies.
Other FDA presentations provided the basis for supplement submission types and gave examples of how changes should be filed and provided some insight into ICH Q12. There is some confusion in the industry of when to draw the line between PAS and CBE-30 submissions, but some clarity was provided by FDA reviewers. The presenters also provided examples of common supplemental changes and their appropriate categories and requirements for submission as well as examples of annual reportable changes.
While there were other good sessions especially on treating COVID 19, a panel with Dr. Scott Gottlieb, the previous Commissioner of FDA and two other physicians that gave their perspectives on the nature of and the impact of the COVID pandemic. Dr. Gottlieb provided some rather interesting takes on the potential vaccine candidates. He also discussed the perceived politicization of the FDA. Very interesting indeed. All the participants were excited about the latest news on the Pfizer vaccine and hoped that the final analysis will bear out the initial optimism. All recognized that therapeutics and vaccines would be a hedge against the pandemic but with the large scale, cold storage distribution required, acknowledged that it will take time and is quite a herculean logistical task to get the vaccine out to the general public.
See you all tomorrow for day three.