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Which of the statements below is true about pharmaceutical or drug packaging? a.) FDA maintains tight control over regulations b.) cost is a major consideration when designing a package c.) advertising and communicating with the consumer is important for both prescription and OTC drugs.  d.) shelf life is always shorter than for food so must choose material appropriately.

The Food and Drug Administration (FDA) is responsible for: A. Requiring drug manufacturers to provide notice that a new drug is safe. B. Recalling pharmaceuticals only after harm has occurred. C. The approval before a new drug can be marketed. D. The assumption that the manufacturer of drugs would have conducted safety tests before marketing a new drug and protocols have been established.

Name some pharmacology math conventions that have been instituted to keep patients safer.

To get approved by the FDA generic drugs have to demonstrate the following: That their bio availability is the same as brand name drug That their bio equivalence is the same as the brand name drug That their bio availability AND bio equivalence is the same as the brand name drug None of the above

Clinical trials can be designed to demonstrate that a new technology offers measurable, relevant benefits, in terms of safety, clinical effectiveness, and in some instances, cost-effectiveness True False

THE LEGAL SYSTEMDefine the following terms using Medical Law And Ethics Sixth Edition: 1. Checks and balances2. Civil/Private law3. Criminal/Public law4. Tort law (Intentional vs Unintentional)5. False Imprisonment6. Libel7. Slander8. Negligence9. Felony10. Misdemeanor

Create a list of ten drugs and include each of the following: Chemical name Generic name Official name Trade or brand name

3. An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw. This change can be implemented: O A. Immediately, as it is not a safety assessment. O B. Once the protocol is finalized and submitted to the FDA. O C. Once the protocol and consent form updates are approved by the IRB. O D. As soon as the study sponsor advises that their decision is final to remove these blood draws. If already serving as a member of the IRB, a clinical investigator can participate in the review of her own clinical protocol. O A. TRUE O B. FALSE An IRB may perform an expedited review of a protocol or informed consent form change if the change involves no more than minimal risk to study participants. O A. TRUE O B. FALSE