Regulatory Affairs Certification (RAC) Practice Exam

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At what timeframe after submitting an NDA will FDA provide the organization with an opportunity to meet with agency reviewing officials to inform applicants of the general progress and status of their application?

60-day conference.
90-day conference.
120-day conference.
180-day conference.

The correct answer is: 90-day conference.

The timeframe for the FDA to provide an opportunity for applicants to meet with agency reviewing officials after submitting a New Drug Application (NDA) is set at 90 days. This 90-day conference serves as a crucial checkpoint in the review process where the FDA communicates the general progress and status of the NDA. This meeting allows the applicant to gain insights into any issues or concerns that may have arisen during the review and to discuss the path forward. During this conference, the applicant can address specific aspects of the application and understand better the FDA's perspective and any additional information or data that may be required. This meeting is a part of the FDA's commitment to maintaining open communication with applicants during the review process, fostering collaboration, and ensuring that the application meets the regulatory requirements efficiently as it progresses through the review timeline.