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The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
These are lists of investigational drugs: List of investigational analgesics; List of investigational antidepressants; List of investigational antipsychotics; List of investigational anxiolytics; List of investigational attention deficit hyperactivity disorder drugs; List of investigational autism and pervasive developmental disorder drugs
This is a list of investigational autism and pervasive developmental disorder drugs, or drugs that are currently under development for clinical use in the treatment of autistic spectrum disorders and/or other pervasive developmental disorders but are not yet approved.
List of investigational analgesics; List of investigational autism and pervasive developmental disorder drugs; Lists of investigational drugs; List of investigational sexual dysfunction drugs; List of investigational sleep drugs; IONIS-GCCRRx; Isomyosamine; ITI-333
Detailed subheadings for each module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of others differ based on national requirements. However, investigational new drugs meant for emergency use or treatment applications and not for commercial distribution are not subject to the CTD requirements. [5] [6]
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
List of investigational antipsychotics; List of investigational attention deficit hyperactivity disorder drugs; List of investigational obsessive–compulsive disorder drugs; List of investigational social anxiety disorder drugs; ITI-1549
Osteoporosis, including drug- and cancer-related osteoporosis, giant cell tumour of bone and hypercalcaemia of malignancies: Hypercholesterolaemia, cataract, urinary retention, hypocalcaemia, osteonecrosis of the jaw and anaphylaxis. Gemtuzumab ozogamicin: IV: CD33 antibody that induces apoptosis of the tagged cell. Acute myeloid leukaemia