FDA’s Newest Designation - Platform Technology: Is It Worth It?
(Thursday, May 30, 2024) This week the FDA released its “Platform Technology Designation Program” to formally recognize well-understood and reproducible technologies in FDA-approved drugs or biologics that could be used for future product development and approvals. It is important to understand the difference between this and the cross-referencing process used commonly to leverage previously submitted information for new applications. Sponsors frequently cite “prior knowledge” by cross-referencing their previously submitted IND, NDA, or BLA applications in support of their new applications. The letter of authorization for the previous application, either self or from a collaborator/partner, allows the FDA to use prior findings of safety and/or effectiveness from the previous applications for the new application. In the case of 505(b)(2) and generic drug (505j) applications, FDA can use prior findings from other applications without the letter of authorization. The main difference between using cross-reference authorization versus “Platform Technology Designation” seems to be the ability to have pre-submission discussions with the FDA for the use of such designated technology. Such pre-submission discussions would help the sponsor identify the specific utility of previous information for the new application. This is different from the current process where the applicant usually gets feedback on the suitability of the cross-referenced information retrospectively once the application is submitted to the FDA. Being designated as Platform Technology does not change the nature of the information. Parties other than the owner of the designation will still need to get proper authorization from the holder of the information. Sponsors can still use the existing process for using “prior knowledge” and use the information at all stages of development, including pre-submission discussions. The process for requesting this designation is similar to any other designation request where the applicant provides detailed justification for the request, followed by FDA review and grant or rejection of the request. The practical value of this new designation is hard to discern as almost all the benefits are already available through existing processes, and the guidance acknowledges that fact. So, the main intangible benefit may be bragging rights for a new fancy designation from the FDA. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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