Investigational New Drug Application
Monday, October 17, 2011 - 02:43
1. Investigational new drug application abbreviated as INDA is a mandatory requirement filed with the FDA in order to seek permission for administering a new drug under investigation to Human subjects after completion of the preclinical studies on it. 2. It confers protection to the subjects and also sees that the investigational plan is efficient and designed to achieve its required objectives. 3. The sponsor of the drug is responsible for the initiation of clinical trials. 4. He might be an individual i.e. sponsor-investigator, a pharmaceutical company, governmental agency, academic institution or private or public organization. 5. The INDA is filed with the FDA under Title 21, Code of Federal Regulations Section 312- the guidelines for preapproval of all clinical testing's are specified. 6. CONTENT OF INDA  (i). All the requirements for submitting an INDA are prescribed in the Code of Federal Regulations and are submitted under a cover sheet (Form FDA- 1571) (1). (ii). The items required are: - Name, address and telephone number of the sponsor of the drug. - Name and title of the person responsible for monitoring the conduct and progress of the investigation. - Names and titles of the persons responsible for the review and evaluation of information relevant to the safety of the drug. - Name and address of any contract research organization involved in the study (if any). - Identification of the phase/phases of clinical investigation to be conducted. - Introductory statement and general investigational plan including, name of drug and all active ingredients, structural formula and pharmacological class, formulation, route of administration, and broad objectives and planned duration of study. - Description of the investigational plan. The reason for selecting a drug or research study. Indications to be studied, approach to evaluation of the drug, types of studies, estimated number of subjects to be given the drug, and any risks anticipated based on animal studies. - Brief summary of previous experience with the drug, including reasons if the drug is withdrawn. - Chemistry and manufacturing control information like physical, chemical and biologic characteristics, product stability during the clinical investigation. - Pharmacological and Toxicological information. - If the drug is a combination of previously investigated components, then preclinical and clinical data of these components when given singly and in combination. - Clinical protocol for planned study. - Commitment that an "Institutional Review Board" (IRB) has approved the study and will continue to monitor the investigation. - Investigators brochure. - Commitment not to begin clinical investigations until IND is in effect signature of the sponsor or authorized representative and the date of signed application. 7. After submission of IND to the FDA, it is assigned to the various divisions of Center for Drug Research and Evaluation wing of the FDA for its review and evaluation. 8. The FDA has 30days from the receipt of IND to decide whether the proposed clinical trial should proceed or not. If the sponsor is not contacted within 30days, the trial may proceed. 9. Meanwhile reviewers at FDA may put a "Clinical Hold" on the proposed Clinical trials at any time. This prevents human testing of drug. It may be due to the following reasons: - If there is any unreasoned threat to the safety of the trial subjects i.e. if the subjects face any illness or injury due to treatment. - Insufficient data to assess patient risks. - If the investigators involved in the study do not meet the necessary requirements with respect their qualification. - Misleading or incomplete investigators brochure. 10. In case if all the requirements for FDA approval are satisfied an IND is granted. Once an IND is in effect, all the proposed changes to the original IND thereafter, must be submitted as amendments for approval. References: 1. Ansel's Pharmaceutical Dosage forms and Drug delivery systems, 8th Edition, Pg: 44-45. 2. The Science and Practice of Pharmacy: Remington Pharmaceutical Sciences, 21st Edition, Volume 1, Pg: 965-967, Published By Lippincott William & Wilkins. "This Blog Contains No Plagiarized Material"