CLIA and FDA Regulations Questions and Answers(A+ Solution guide)

Biologics Product Licensing: Minimal Change requires... - report on an annual basis Biologics Product Licensing: Moderate Change requires... - report at time of implementation Biologics Product Licensing: Substantial Change requires... - FDA approval before implementation CBER - Center for Biologics Evaluation and Research (Regulation and Oversight) CBER Registration must include: - -Ownership - Location - Manufacturing activities - List of every blood product in commercial distribution -License=products -registration = approval of manufacturing by the FDA CDER - Center for Drug Evaluation and Research (Related regulation and cGMP) Certificate of Accreditation Requirements - -follow regulations -comply with requirements of accreditation program-permit random sample validation or inspection in response to a complaint or in response to a substantial allegation on noncompliance -accrediting agencies: AABB, JHCO, CAP CFR - Code of Federal Regulations -Proposed Rules: solicit public comments -Final rules: published as a law Changes in manufacturing must be reported to the FDA. Changes are reported based on the answer to this question: - Doe the change have the potential to adversely affect the product? CLIA - Clinical Laboratory Improvement Amendments ('88) -replaced the clinical laboratory improvement act (1967) -applies anywhere patient testing is done