Investigative new drug application

Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

LIST NUMBERS OF ALL INVESTIGATIONAL NEW DRUG APPLICATIONS <21 CFR Pan 312), NEW DRUG OR ANTIBIOTIC APPLICATIONS (S CFR Part 3U). DRUG MASTER FILES (2i CFR Pan 314.420A AND PRODUCT LICENSE APPLICATIONS <21 CFR Part 601) REFERRED TO IN THIS APPLICATION. 

Investigational New Drug Applications (INDs), NDAs, Premarket Approval Applications (PMAs), Premarket Notifications (5 lO(k)s), Investigational Device Exemptions (IDEs), Biological Master Files (BMFs) and DMFs that are referenced in the current application. 

Intellectual Property In general, the investigator retains ownership and development rights to their invention, consistent with Bayh-Dole provisions [4]. The investigator is expected to submit an Investigational New Drug Application (INDA) with the FDA under their own sponsorship. Specific information can be found at the NIH-RAID website. 

Asphalt chemicals, ethyleneamines application, 8 500t, 506 Asphalt emulsifier amine oxides, 2 473 fatty acid amides, 2 458 Asphalt emulsions, 10 131 Asphaltenes, in petroleum vacuum residua, 18 589-590 Asphyxiants, 21 836 Aspirating aerators, 26 165-169 compressed, 26 168-169 propeller driven, 26 168 submersible, 26 169, 170t subsurface, 26 168 Aspiratory, 11 236-237 Aspirin, 4 103-104, 104t, 701 22 17-21. See also Acetylsalicylic acid as trade name, 22 19 for cancer prevention, 2 826 Aspirin resistance, 4 104 ASP oil recovery process, 23 532-533 Assay format, competitive, 14 142 Assay limits, in Investigational New Drug Applications, 18 692 Assays, for silver, 22 650. See also... 

Investigator s Brochure, in Investigational New Drug Applications, 25 691 Investigator information, for Investigational New Drug Applications, 25 690 Investment... 

Pharmacology information, in Investigational New Drug Applications, 78 692-693 Pharma companies, 77 16 Pharmacophores, 70 326, 327 boranes as, 4 227-228 chemical centers in, 70 382... 

Sumitomo one-step MIBK process, 16 339 Summary report, in Investigational New Drug Applications, 18 693 Summer flounder aquaculture, 3 189... 

Lumpkin, M. (1996). Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including well-characterized, therapeutic, and biotechnology-derived products, http //www.fda.gov/cder/guidance/phasel.pdf... 

Drug Master Files Investigational New Drug Application New Drug Application... 

IND Investigational New Drug application, filed with FDA after preclinical testing is complete asking for permission to proceed with human tests. 

Investigational new drug application — submission and review process. 

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