CLIA and FDA Regulations Exam Questions With Verified Answers.

CLIA and FDA Regulations Exam Questions With Verified Answers. -Evolved from initial actions taken to address diphtheria epidemic -Established requirements for premarketing product/facility licensure & labeling controls. -Emphasis on public health concern that products are safe & do not become vectors for spreading disease -Began regulation of biologics - answerPublic Health Service Act (1944) -in response to sulfanilamide elixir mass poisoning -Set of laws passed by Congress giving authority to the government (FDA) to oversee safety of food, drugs, cosmetics -Emphasis on consumer protection -Concern with product composition (i.e. proper ingredients, right quantity, not adulterated, no misleading labeling, not contaminated) -Established federal regulatory control ensuring the safety of new drugs - answerFederal Food, Drug, and Cosmetic Act (1938) Center for Biologics Evaluation and Research (Regulation and Oversight) - answerCBER Center for Drug Evaluation and Research (Related regulation and cGMP) - answerCDER Organization of Regulatory Affairs (inspection and field activities) - answerORA Biological products (general) - answerFDA Regulations: Title 21 600 Licensing - answerFDA Regulations: Title 21 601 cGMP for blood - answerFDA Regulations: Title 21 606 Blood Establishment Registration - answerFDA Regulations: Title 21 607 General Biologic Products Standards - answerFDA Regulations: Title 21 610 General Requirements for Blood - answerFDA Regulations: Title 21 630 Additional Standards for Blood - answerFDA Regulations: Title 21 640 Additional Standards for Diagnostic Substances for Laboratory Tests - answerFDA Regulations: Title 21 660 Code of Federal Regulations -Proposed Rules: solicit public comments -Final rules: published as a law - answerCFR Represent FDA's current thinking on a newly introduced regulation, a new technical, medical or scientific topic, or a current regulation -not legally binding -faster to implement than changing a regulation -available on FDA website -most up to date thoughts - answerFDA Guidance Documents -Ownership - Location - Manufacturing activities - List of every blood product in commercial distribution -License=products