FDA OCP Confirms Combination Product Regulatory Pathway for RapiGenes Autoinjector Platform
RapiGenes announced today that the U.S. Food and Drug Administration Office of Combination Products (OCP) has confirmed the drug-device combination product regulatory pathway for its novel autoinjector platform. This designation enables a streamlined development path under 21 CFR Part 3.2(e).
The OCP determination classifies RapiGenes autoi-njector as a combination product with the Center for Drug Evaluation and Research (CDER) serving as the lead review center. This classification provides clarity on the pre-submission, investigational new drug (IND), and marketing application requirements.
This regulatory milestone validates our platform approach and accelerates our path to IND submission, said Dr. Sarah Chen, CEO of RapiGenes. With the OCP designation confirmed, we can proceed with our IND-enabling studies and pre-IND meeting package.
RapiGenes is currently preparing its pre-RFD (Request for Designation) package and expects to file its IND application in Q3 2025. The company is actively seeking government and commercial partners for co-development of specific drug-device combinations.