- IMP MEANING MANUAL
- IMP MEANING TRIAL
For specific information, click on a link to go directly to a section or web page. Each of the sections below contains information from CDER to assist you in the IND application process. This web site is designed for individuals from pharmaceutical companies, government agencies, academic institutions, private organizations, or other organizations interested in bringing a new drug to market. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk. Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. Finally, commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
IMP MEANING TRIAL
Also, information on the qualifications of clinical investigators-professionals (generally physicians) who oversee the administration of the experimental compound-to assess whether they are qualified to fulfill their clinical trial duties. Clinical Protocols and Investigator Information - Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
Manufacturing Information - Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product.
Also included are any previous experience with the drug in humans (often foreign use).
Animal Pharmacology and Toxicology Studies - Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. The IND application must contain information in three broad areas: Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.Įmergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR, Sec. At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.Īn Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.įDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans. The IND is the means through which the sponsor technically obtains this exemption from the FDA.ĭuring a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. 
Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement.
Physician Request for a Single Patient IND for Compassionate or Emergency UseĬurrent Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Emergency Use of an Investigational Drug or Biologic. IMP MEANING MANUAL
Manual of Policies and Procedures (MaPPs).Laws, Regulations, Policies and Procedures.
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