Regulatory Submissions & Approvals Flashcards
7 cards from real CTA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Submissions & Approvals flashcards as text
A sponsor receives an FDA Refuse to File (RTF) letter 60 days after submitting an NDA. What is the most likely reason?
Answer: The application lacks sufficient data or has significant organizational deficiencies preventing substantive review
An RTF is issued during the 60-day filing review if the NDA is incomplete or so disorganized that a substantive scientific review cannot begin.
Under EU CTR 536/2014, what is the maximum timeline for the initial assessment phase (Part I) of a clinical trial application for a non-complex trial?
Answer: 30 days
For standard (non-complex) trials, the initial Part I assessment under EU CTR must be completed within 30 days.
What is the key distinction between a sponsor-investigator and a sponsor in clinical trial regulatory submissions?
Answer: A sponsor-investigator is both the individual who initiates the trial and conducts it, assuming all sponsor and investigator obligations
A sponsor-investigator is typically an academic researcher or physician who both holds the IND and directly conducts the clinical investigation, fulfilling all regulatory obligations of both roles.
Which FDA guidance describes the recommended format for electronic submissions to the Agency using the eCTD standard?
Answer: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications
The FDA's eCTD guidance document specifies technical and format requirements for electronic Common Technical Document submissions.
What is the significance of a Breakthrough Therapy designation from the FDA compared to Fast Track designation?
Answer: Breakthrough Therapy provides more intensive FDA guidance and organizational commitment, including senior management involvement in development
Breakthrough Therapy includes all Fast Track benefits plus more intensive guidance from senior FDA staff and cross-disciplinary project management to expedite development.
In the context of regulatory submissions, what does 'grandfathering' refer to for IND annual reports?
Answer: Previously approved drugs or ongoing INDs are exempted from new regulatory requirements introduced after their initial approval
Grandfathering allows existing INDs or approved products to remain under the rules in effect at the time of their approval rather than being subject to new requirements retroactively.
Which international body harmonizes technical requirements for registration of pharmaceuticals for human use across the US, EU, and Japan through guidelines such as ICH E6?
Answer: International Council for Harmonisation (ICH)
The International Council for Harmonisation (ICH) develops harmonized technical guidelines including GCP (E6), clinical study reports (E3), and CTD format (M4) used by regulatory authorities worldwide.