Which of the following is a key requirement of drug approval?

Prepare for the iCEV Elanco Veterinary Medical Applications Certification Test. Use flashcards and multiple choice questions with hints and explanations to secure your certification!

The key requirement of drug approval is the testing for safety and effectiveness. This process is critical because it ensures that new medications are both safe for human use and effective in treating the intended conditions. Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States, demand comprehensive clinical trials that provide robust data demonstrating that the drug meets these necessary criteria before it can be approved for public use.

Testing for safety involves rigorous evaluations to identify any potential adverse effects and determine an acceptable level of risk associated with the drug. Effectiveness testing is essential to confirm that the drug achieves its intended therapeutic outcomes in the population for which it is prescribed. This dual focus is integral to protecting public health and maintaining trust in the healthcare system, as it assures that only drugs meeting strict safety and efficacy standards reach the market.

The other options, such as submission of marketing strategy, determination of cost and pricing, and submission of customer feedback, do not directly influence the approval process. While they may be important for post-marketing strategies and overall business practices, they are not prerequisites for a drug's approval by regulatory authorities.

Subscribe

Get the latest from Examzify

You can unsubscribe at any time. Read our privacy policy