Regulatory agencies, like the FDA, help keep our medicines safe and effective. Here's how they do it:
Preclinical Testing: Before any drugs can be used by people, they are first tested in labs and on animals. This helps find out if there are any risks.
Clinical Trials: After preclinical testing, drugs go through clinical trials. These trials happen in three phases (I, II, III) and involve human volunteers. The goal is to see if the drug is safe and works well.
Review and Approval: Once testing is done, all the data is sent in for review. Only drugs that meet the safety and effectiveness standards get approved.
Post-Market Surveillance: Even after a drug is approved, it is still monitored to make sure it remains safe for use.
This process helps protect people and ensures that the medicines we use are helpful and safe.
Regulatory agencies, like the FDA, help keep our medicines safe and effective. Here's how they do it:
Preclinical Testing: Before any drugs can be used by people, they are first tested in labs and on animals. This helps find out if there are any risks.
Clinical Trials: After preclinical testing, drugs go through clinical trials. These trials happen in three phases (I, II, III) and involve human volunteers. The goal is to see if the drug is safe and works well.
Review and Approval: Once testing is done, all the data is sent in for review. Only drugs that meet the safety and effectiveness standards get approved.
Post-Market Surveillance: Even after a drug is approved, it is still monitored to make sure it remains safe for use.
This process helps protect people and ensures that the medicines we use are helpful and safe.