What are the regulations governing the clinical trials of drugs?

Clinical trials are a critical part of the drug-development process. In California, there are several laws and regulations that govern the clinical trials of drugs. First, the California Health and Safety Code requires that a drug being tested in a clinical trial be approved for safety and effectiveness by the federal Food and Drug Administration (FDA). These drugs must be labeled with a special "investigational drug" label, indicating that the drug is intended for research use only. Second, federal law requires that all clinical trials be approved by an Institutional Review Board (IRB) before the trial begins. The IRB is an independent body that reviews the scientific merits of the research and the safety of the drug before it is administered to humans. The IRB must also make sure that participants are adequately informed of the potential risks of taking the drug. Finally, the California Administrative Code contains additional regulations that govern the conduct of clinical trials. For example, the code requires researchers to maintain records of all trial results, as well as to protect the safety of participants and ensure privacy. These laws and regulations ensure that clinical trials involving drugs meet the highest standards of safety. By following these laws and regulations, pharmaceutical companies are able to bring new and innovative drugs to market, while protecting the health and safety of the public.

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What are the regulations governing the clinical trials of drugs?

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