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
Which ICH guideline specifically addresses the format and content of clinical study reports submitted in regulatory applications?
Answer: ICH E3
ICH E3 provides the structure and content requirements for clinical study reports used in regulatory submissions.
A sponsor wants to claim a new indication for an already-approved drug. Which type of NDA/BLA submission is most appropriate?
Answer: Efficacy Supplement
An Efficacy Supplement is required when adding a new indication, which involves new clinical data supporting the change.
What is the role of the Reference Member State (RMS) in the EU Mutual Recognition Procedure (MRP)?
Answer: The RMS conducted the initial national assessment and prepares the assessment report used by other member states
In the MRP, the RMS is the member state that initially approved the product and its assessment report forms the basis for mutual recognition by other countries.
Under 21 CFR 312.33, what is the primary content requirement of an IND Annual Report?
Answer: Progress of investigations, safety summary, and any protocol changes during the year
The IND Annual Report must include a brief summary of the status of each study, safety information, and any significant protocol amendments.
Which designation provides an incentive for developing drugs for rare diseases affecting fewer than 200,000 people in the US?
Answer: Orphan Drug Designation
Orphan Drug Designation, granted by the FDA Office of Orphan Products Development, provides 7-year market exclusivity and tax credits for drugs targeting diseases affecting fewer than 200,000 US patients.
Which document must a sponsor maintain that lists all investigators authorized to conduct the clinical trial under an IND?
Answer: Form FDA 1572 (Statement of Investigator)
FDA Form 1572 is signed by each investigator and describes their qualifications, commitments, and the study site, and is maintained in the IND.
What does the term 'rolling review' mean in the context of FDA approval pathways?
Answer: Reviewing completed sections of a marketing application as they are submitted rather than waiting for the complete dossier
Rolling review allows sponsors to submit completed sections of their NDA/BLA for FDA review before the full dossier is finalized, expediting overall review time.