RAC Regulatory Agency Interactions 2

Question 1

What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA?

Accepted Answer

To get FDA feedback on planned submissions or study designs before they are submitted

Answer

To obtain binding approval before filing

Answer

To negotiate user fees for the application

Answer

To request expedited review of a pending application

Question 2

Under 21 CFR Part 312, what is the maximum number of days FDA has to place a proposed IND on clinical hold after receiving the application?

Accepted Answer

30 days

Answer

15 days

Answer

45 days

Answer

60 days

Question 3

Which FDA meeting type is categorized as 'Type B' for drug development?

Accepted Answer

End-of-Phase 2 meetings and pre-NDA/BLA meetings

Answer

Meetings requested to discuss labeling post-approval

Answer

Meetings to resolve manufacturing disputes

Answer

Post-market surveillance planning meetings

Question 4

What must a sponsor do if FDA issues a Complete Response Letter (CRL) for an NDA?

Accepted Answer

Respond to all deficiencies identified or request a meeting to discuss them

Answer

Withdraw the application immediately

Answer

Resubmit a new NDA from scratch

Answer

Automatically receive approval after 6 months

Question 5

Which program allows FDA to expedite the development and review of drugs for serious conditions where preliminary evidence shows substantial improvement over available therapies?

Accepted Answer

Breakthrough Therapy designation

Answer

Fast Track designation

Answer

Priority Review designation

Answer

Accelerated Approval pathway

Question 6

When interacting with the EMA, what is the role of a Rapporteur and Co-Rapporteur?

Accepted Answer

They are CHMP members assigned to lead assessment of a marketing authorization application

Answer

They serve as legal representatives for the applicant

Answer

They conduct GMP inspections at manufacturing sites

Answer

They manage post-market surveillance programs

Question 7

Which of the following best describes an FDA Advisory Committee meeting?

Accepted Answer

A public meeting where independent experts provide non-binding recommendations to FDA

Answer

A binding vote that FDA must follow to approve or reject a product

Answer

A closed hearing where only the applicant and FDA attend

Answer

A mandatory step for all NDA/BLA submissions