Skip to Content
World of Compliance Module
Back to Unit List
Manufacturing and Product Quality
abridged
Learning Objectives
Introduction
Surveillance
"For Cause" Inspections
Pre-Approval Program
Biologic Products
Conducting an Inspection
Recalls, Shortages, and Certificates
Guidance and Policy
Knowledge Check
Certificate of Completion
Module Home
CDER World
CDERLearn Home
DRUGS Home
Back
Next
Comment
Knowledge Check
Of the answers below, which of the categories of products that are submitted as biologics license applications (BLA) apply?
Therapeutic synthetic peptide products of 40 or fewer amino acids.
Monoclonal antibody products for in vivo use and therapeutic recombinant DNA-derived products.
Therapeutic DNA plasmid products.
All of the above
Regulations for biologic products are covered under what Code of Federal Regulations under the Public Health Services Act?
CFR 601.2
CFR 502.5
CFR 605.5
None of the above
"For Cause" inspections are performed when other information, such as product quality complaints, adverse events or data from an application or other source, indicate a potential problem with a firm's products that warrants a more timely investigation. True or False?
True
False
Continue
Lesson status: Incomplete (0% done)
Topic: page 1 of 1 (Lesson: page 14 of 15)
Learner Help
Resources
Exit Module