Regulatory Affairs Certification (RAC) Practice Exam

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Prepare for the Regulatory Affairs Certification (RAC) Exam. Use our study flashcards and multiple choice questions, each featuring hints and explanations. Enhance your readiness for the certification!

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When must a company submit new safety information after an NDA submission?

Within 30 days
Four months after submission
Within 60 days
After the NDA is approved

The correct answer is: Four months after submission

The correct timing for a company to submit new safety information after an NDA (New Drug Application) submission is four months after the initial submission. This timeframe is established to ensure that the regulatory authorities are promptly informed about any significant safety data that emerges after the initial NDA filing. The regulation demands this timely reporting to mitigate risks and ensure ongoing patient safety while the review of the NDA is still underway. It is important for companies to remain vigilant about safety data even after an NDA submission, as new adverse events or findings can affect the evaluation of the drug's benefit-risk profile. Submitting this information within the prescribed timeframe allows the FDA to consider the most current safety data when making their approval decision. The other timeframes mentioned do not align with the regulatory requirements. For instance, the options suggesting a 30-day or 60-day timeframe do not meet the four-month requirement intended for comprehensive safety updates. Additionally, the option indicating submission after NDA approval does not meet the regulatory expectation of proactive safety reporting during the review period. The focus is on ensuring that the FDA has access to all relevant data as they evaluate the drug for approval.