godkännandeprocess (FDA specifik)

New Drug Approval Process [ENGLISH]

After the animal testing stage, FDA decides whether it is reasonably safe for the company to move forward with clinical trials—studies that evaluate the safety and effectiveness of a drug in healthy people and in patients. The drug company submits the results of such studies to FDA for review. The agency conducts a thorough review of the safety and effectiveness data, and considers how the benefits compare to the risks when making a decision of whether or not to approve a drug.

godkännandeprocess (FDA specifik) [SWEDISH]

Ansökan om godkännande (för nytt läkemedel).