Question

What does the FDA require from a drug company before approving a new drug to be sold as a prescription medicine?

1) Results of three phases of human testing
2) Approval from the medical community
3) Proof of effectiveness
4) Marketing plan

Answer 1

The FDA requires results of three phases of human testing, proof of effectiveness, and a marketing plan from a drug company before approving a new drug to be sold as a prescription medicine.

Step-by-step explanation:

The FDA requires several steps from a drug company before approving a new drug to be sold as a prescription medicine:

1. Results of three phases of human testing: To ensure safety and effectiveness, drugs must go through three phases of clinical trials involving human subjects.
2. Proof of effectiveness: The drug company must provide evidence that the drug is effective in treating the condition for which it is intended.
3. Marketing plan: Although a marketing plan is not directly required for FDA approval, it is necessary for the drug company to have a plan in place for how they will promote and distribute the drug once it is approved.