A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?
- Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.
- Consult with the legal department to discuss the best course of action.
- Review the regulatory guidelines to determine how to proceed.
- Request a meeting with the regulatory authority to discuss the application.
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