Which statements regarding the role of the U.S. Food and Drug ...

[penguins]

Which statements regarding the role of the U.S. Food and Drug Administration (FDA) are true? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Standard Text: Select all that apply.
 
  1. The FDA is responsible for improving the health of Americans.
  2. The FDA publishes a summary of the standards of drug purity and strength.
  3. The FDA ensures the availability of effective drugs.
  4. The FDA takes action against any supplement that is deemed to be unsafe.
  5. The FDA facilitates the availability of safe drugs.

Question 2

The nurse is participating in the New Drug Review step for a new therapeutic agent. Which activities will the nurse most likely perform during this phase of the drug approval process? Note: Credit will be given only if all correct choices and no incorrect choices are selected. Standard Text: Select all that apply.
 
  1. Attend meetings to finalize the brand name for the drug.
  2. Check on the results of animal testing.
  3. Survey for harmful effects in a larger population.
  4. Evaluate the results of the drug on cultured cells.
  5. Provide the medication to large groups of people with a particular disease.

[carolinefletcherr]

Answer to Question 1

1,3,4,5
Rationale 1: The FDA mission is to protect public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biologic products, medical devices, the nation's food supply, cosmetics, and products that emit radiation.
Rationale 2: It is the role of the U.S. Pharmacopeia (USP) to publish a summary of drug standards (purity and strength).
Rationale 3: Ensuring the availability of effective drugs is one of the FDA's roles.
Rationale 4: It is the FDA's role to take action against any supplement that is deemed to be unsafe.
Rationale 5: It is the role of the FDA to facilitate the availability of safe drugs.
Global Rationale: One of the missions of the CDER branch of the FDA is to improve the health of Americans. It is the role of the U.S. Pharmacopeia (USP) to publish a summary of drug standards (purity and strength). Ensuring the availability of effective drugs is one of the FDA's roles. It is the FDA's role to take action against any supplement that is deemed to be unsafe. It is the role of the FDA to facilitate the availability of safe drugs.

Answer to Question 2

1,2
Rationale 1: During the NDA or the third stage of the drug approval process, the drug's brand name is finalized.
Rationale 2: During the NDA stage of the drug approval process, animal testing may continue.
Rationale 3: Surveying for harmful effects in a larger population occurs during the post-marketing surveillance step of the drug approval process.
Rationale 4: Evaluation of the results of the drug on cultured cells occurs during the preclinical investigation step of the drug approval process.
Rationale 5: Providing the medication to large groups of people with a particular disease occurs during the clinical phase trials, which is in the second stage of the drug approval process.
Global Rationale: During the NDA or the third stage of the drug approval process, the drug's brand name is finalized. Animal testing may continue during this stage. Surveying for harmful effects in a larger population occurs during the post-marketing surveillance step of the drug approval process. Evaluation of the results of the drug on cultured cells occurs during the preclinical investigation step of the drug approval process. Providing the medication to large groups of people with a particular disease occurs during the clinical phase trials, which is in the second stage of the drug approval process.

[penguins]

Thank you!

[carolinefletcherr]

Always glad to help...