Pre-IND Consultation Program Glossary
For the purpose of the information contained on the Pre-IND Development Program web site, the following definitions apply (21 CFR 314.3(b):
| Agency | The Food and Drug Administration |
|---|---|
| Applicant | Any person or company who submits an application or abbreviated application or an amendment or supplement to them to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application. |
| Drug Product | A finished dosage form, for example, tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients |
| Drug Substance | An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates use in the synthesis of such ingredient. |
| DAIOP | Division of Anti-Infective and Ophthalmology Drug Products, Office of Antimicrobial Resistance |
| DAVP | Division of Antiviral Drug Products, Office of Antimicrobial Products |
| DSPTP | Division of Special Pathogen and Transplant Products, Office of Antimicrobial Resistance |
| DMF | Drug Master File. A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. (CDER Guidance Document on Drug Master Files or 21 CFR 314.420.) |
| IND | Investigational New Drug application (also synonymous with "Notice of Claimed Investigational Exemption for a New Drug"). (CDER Guidance Document on Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs or 21 CFR 314.312.) |
| LOA | Letter of Authorization, meaning a written statement by the holder or designated agent or representative permitting the FDA to refer to the information contained in a document (DMF, IND, etc.) in support of another person's document. |
| OAP | Office of Antimicrobial Products, Center for Drug Evaluation and Research (CDER) |
| Sponsor | An individual, partnership, corporation, or Government Agency and may be a manufacturer, scientific institution, or an investigator regularly and lawfully engaged in the investigation of new drugs, who assumes responsibility for an investigation of a new drug, including responsibility for compliance with applicable provisions of the Federal Food, Drug, and Cosmetic Act and related regulations. |
| Topical Microbicide | Products classified by FDA which act to prevent vaginal transmission of sexually acquired diseases. |
| Topical Microbicide Working Group | A cross-disciplinary working group within the FDA whose purpose is to develop and coordinate FDA regulatory and scientific policy regarding products to prevent vaginal transmission of sexually acquired diseases. |
Note: All Office of Antimicrobial Products Pre-IND communications are considered informal under 21 CFR 10.90(b)(9) and represent the best judgment of the Office at this time. The communications do not necessarily represent the formal position of the Center for Drug Evaluation and Research or the Food and Drug Administration, and does not bind or otherwise obligate the Center or Agency to the views expressed. Please direct any comments to Pre-IND for Topical Microbicides.