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please help me from 9-12 thank you 9. FDA can take action against drug manufacturer's but not individuals in the firm. True or False 10.
please help me from 9-12 thank you
9. FDA can take action against drug manufacturer's but not individuals in the firm. True or False 10. Matching I e FD-483 a. Drug which caused birth defects CDER b. FDA group that controls devices Phase I c. Document from FDA which requires a response, within 15 days, or other action will be taken CBER d. FDA group that controls drugs Phase III e. Notice of Inspection Observations f. FDA Group that controls biologics CDRH GLP's g. Drug which contained poisonous substance which eventually led to deaths h. Where efficacy is determined Warning Letter a Thalidomide i. Initial safety studies Sulfanilamide j. Regulation governing preclinical testing 11. is the practice used to prevent mix-ups of labeling, drug product containers, closures, components, etc. a. Accountability b. Segregation c. Inventory d. Identification 12. Areas for storage of untested components are Step by Step Solution
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