Investigational New Drugs Application Process

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... 

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

Investigational new drug application — submission and review process. 

Guarino, R.A. The investigational new drug application and the investigator s brochure. In New Drug Approval Process, 3rd Ed. Marcel Dekker, Inc. New York, 2000 100, 74-75. 

Once the OOPD determines that the proposed compound is for a disease or condition that is rare in the U.S., the request will be forwarded to the responsible division for formal review and direct response. The OOPD monitors the review process within the respective CDER/CBER reviewing division and, where possible, assists in resolving specific issues that may arise during the review process. It should be understood that protocol assistance provided under the Act does not waive the necessity for the submission of an Investigational New Drug Application (IND) by sponsors planning to conduct clinical trials with the product. 

In the US, an IND (Investigational New Drug) application has to be filed with the FDA. For other countries, a notification has to be submitted to the respective regulatory authorities. For example, Clinical Trial Exemption (CTX) applications are required for the UK, Clinical Trial Notification (CTN) and CTX for Australia, and a Clinical Trial Certificate (CTC) for Singapore and the European Agency for the Evaluation of Medicinal Products (EMEA). A more extensive discussion concerning regulatory authorities and the processes and procedures of applications is presented in Chapters 7 and 8. The relevant authority will review the application. A positive response from the authority is required before the trial can commence. 

The issue of reproducibility of process parameters and of achievable product quantity and quality is of highest significance as this will ultimately be evaluated by the regulatory agencies. For Investigational New Drug applications (IND) and Process Licence Applications (PLA), rather specific requirements must be met with respect to the minimal number of product batches analyzed. For INDs, no less than three product runs are recommended. Shorter batch processes (5-7 days) have... 

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