The FDA regulates a variety of items from foods, dietary supplements, human drugs, vaccines, blood products, medical devices, electronic products, cosmetics, veterinary products and tobacco products. Products that are approved by the FDA are not required to place the FDA label on the product. Clinical trials are a way to test new products to determine if they are safe for the overall public health interest. In phase one testing, healthy people are used. During phase one, doctors determine the best way to transfer the treatment and also determine the volume of drug that can be safely administered to the person. In Phase two, subjects with the disease are added to the subjects from phase one. Phase two helps determine how effective the drug is. If the drug is considered effective for the diseased subjects, the testing moves onto phase three. In phase three, a large number of people with the disease are added to the testing pool to further determine the effectiveness of the drug towards the disease. In phase four, studies are done on the effect of the drug on various populations and a study of the side effects. Informed consent is the process of releasing written information to the person who is involved in the study, and having the person sign the informed consent form showing that the information of the study was clearly articulated. The name of the trial is “A Multiple-Site, Phase 1/2, Safety and Efficacy Trial of a Recombinant Adeno-associated Virus Vector Expressing RPE65 (rAAV2-CB-hRPE65) in Patients
