Under FDA’s laws (21 CFR 312.2), except a medical investigation meets the restricted criteria in that regulation, an IND is required for all scientific investigations of products that are subject to part 505 of the FD&C Act. A. FDA is conscious that unapproved hashish or hashish-derived products are getting used for the therapy of numerous medical situations together with, for example, AIDS losing, epilepsy, neuropathic ache, spasticity related to multiple sclerosis, and most cancers and chemotherapy-induced nausea. The company also has approved Marinol and Syndros for therapeutic uses within the United States, together with for the treatment of anorexia related to weight loss in AIDS patients.
A. Information for patients on Right to Try (RTT) is available on our web site. RTT is designed to facilitate entry to certain investigational medicine via direct interactions between patients, their physicians and drug sponsors – FDA is not concerned in these choices. Sponsors … Read More