Product Development & Registration Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Product Development & Registration flashcards as text
Under 21 CFR Part 601, which FDA center primarily reviews BLAs for therapeutic biological products such as monoclonal antibodies?
Answer: Center for Drug Evaluation and Research (CDER)
Most therapeutic biological products including monoclonal antibodies and cytokines were transferred to CDER, while CBER retains oversight of vaccines, blood products, and gene/cell therapies.
A sponsor receives a Complete Response Letter (CRL) after FDA reviews an NDA. What does this action signify?
Answer: FDA has identified deficiencies preventing approval and outlines what must be addressed before reconsideration
A CRL is issued when FDA cannot approve an application in its current form, detailing specific deficiencies—clinical, manufacturing, or labeling—that the sponsor must resolve.
What is the concept of 'Quality by Design' (QbD) as applied to pharmaceutical product development under ICH Q8?
Answer: A systematic, science-based approach that begins with predefined objectives and emphasizes understanding product and process knowledge to build quality in from the start
QbD is a proactive development philosophy where quality is designed into a product through deep scientific understanding of formulation and manufacturing variables that affect quality attributes.
Under the Biosimilar pathway (351(k) of the PHS Act), what must an applicant demonstrate beyond showing no clinically meaningful differences from the reference product?
Answer: Biosimilarity based on analytical, nonclinical, and clinical data, and optionally 'interchangeability' requiring additional switching study data
Biosimilar applicants must demonstrate biosimilarity through a totality-of-evidence approach; the higher standard of 'interchangeability' requires additional switching studies showing no diminished safety or efficacy.
What is the primary function of a Design History File (DHF) in the development of a medical device subject to 21 CFR Part 820?
Answer: It contains the records describing the design history of a finished device, demonstrating that the design was developed in accordance with the approved design plan
The DHF compiles all design control records for a device, providing objective evidence that the design development process met requirements under 21 CFR 820.30.
In the EU regulatory system, what is the 'centralised procedure' for medicinal product authorisation?
Answer: A single evaluation by the European Medicines Agency (EMA) leading to a marketing authorisation valid in all EU/EEA member states
The centralised procedure results in a single EMA opinion and a European Commission decision granting a marketing authorisation valid across all EU and EEA countries.
What is the purpose of an End-of-Phase 2 (EOP2) meeting with FDA in the drug development process?
Answer: To discuss the adequacy of Phase 2 studies, the design of Phase 3 trials, and the data needed to support a marketing application
The EOP2 meeting is a critical milestone where FDA provides guidance on whether Phase 2 results are adequate and whether the planned Phase 3 program will support an approvable NDA/BLA.