What is the role of the FDA in research?

What is the role of the FDA in research?

The FDA, or Food and Drug Administration, plays a crucial role in overseeing research related to food, drugs, and medical devices. They ensure that products are safe and effective before they reach the market.

How does the FDA ensure the safety of new drugs?

The FDA requires extensive clinical trials to be conducted by pharmaceutical companies. These trials assess the safety and efficacy of new drugs before they can be approved for public use.

What are the phases of clinical trials?

Clinical trials typically have three phases: Phase 1 tests safety and dosage, Phase 2 evaluates effectiveness, and Phase 3 compares the new drug to standard treatments.

Can the FDA reject a drug application?

Yes, the FDA can reject a drug application if the evidence from clinical trials does not demonstrate that the drug is safe and effective.

What happens after a drug is approved by the FDA?

After approval, the FDA continues to monitor the drug's safety through post-marketing surveillance and can take action if any safety issues arise.