RAC Regulatory Agency Interactions 3

Question 1

What is the standard PDUFA review goal for a Priority Review NDA/BLA?

Accepted Answer

6 months from filing date

Answer

Under PDUFA, Priority Review applications have a 6-month review goal from the filing date, compared to 10 months for Standard Review.

Question 2

During an FDA inspection, what does a Form FDA 483 represent?

Accepted Answer

A notice of inspectional observations of conditions that may constitute violations

Answer

Form FDA 483 lists inspectional observations of conditions that the investigator believes may constitute violations, giving the company an opportunity to respond before further action.

Question 3

What is the purpose of the EMA's Scientific Advice procedure?

Accepted Answer

To offer non-binding guidance on study design, data requirements, and development strategies

Answer

EMA Scientific Advice provides non-binding guidance to developers on methodological, scientific, and regulatory questions during product development.

Question 4

Under the FDA's refuse-to-file (RTF) policy, within how many days of submission can FDA refuse to file an NDA?

Accepted Answer

60 days

Answer

FDA has 60 days from NDA receipt to conduct a filing review and issue a refuse-to-file action if the application is incomplete on its face.

Question 5

Which communication tool do regulatory agencies use to send formal questions to applicants during the review of a marketing authorization application?

Accepted Answer

A List of Questions (LoQ) or Information Request

Answer

During review, agencies such as EMA issue a List of Questions (LoQ) and FDA issues Information Requests or discipline review letters to seek clarification from applicants.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Regulatory Agency Interactions 3