DEFINITION OF 'Investigational New Drug (IND)' Information:
Application of Investigational New Drug (IND) - the first step in the course of consideration of a preparation by the American Management on control of products and drugs (FDA). The application is submitted by the company responsible that developed medicine (sponsor) to FDA.
2019 - Definition of Investigational New Drug (IND) Bank card, Credit online, Lending
Definition of Investigational New Drug (IND) Bank card, Credit online, Lending, Information - 2019
DESTRUCTION OF 'Investigational New Drug (IND)' Information:
Research New Drugs (INDs) get to two categories:
1. Commercial - presented, mainly, by marketing approval of search of the companies for a new preparation
2. (Noncommercial) research - the majority of INDs is given for noncommercial research and has three main types - the Investigator of IND, Use as a last resort IND and Treatment of IND.
Application of IND contains information in three wide areas -
- Pharmacology of animals and research of toxicology: contains preclinical researches, I had to establish, whether the preparation for initial tests in people, and also any previous experience including human use of a preparation is quite safe (such as in the foreign markets).
- Information on the manufacturer: includes information to guarantee that the company can make sufficient parties of a preparation.
- Clinical Protocols and information on the Investigator: contains protocols to define, whether will expose initial tests of human beings to useless risks and include qualifications of clinical investigators who will watch administration of structure.
IND not the application for approval marketing. It is the avenue through which the sponsor receives from Food / Introduction of medicine (FDA) release to the Federal law which prevents an unconfirmed preparation to be transported through frontiers. This release is required as in most cases the sponsor will have to send a research preparation to investigators in other states. To receive release, the sponsor has to submit sufficient data through IND, documenting safety of a preparation for use in human testing.
Actually IND is presented after the sponsor decided through researches on animals that the offered preparation is quite safe for initial use in people, and that it shows the sufficient promise as treatment to justify commercial development. FDA considers the application of IND and solves, whether it is safe to progress for the company to the following stage, i.e. clinical tests in what the preparation is checked in people. The sponsor has to wait within 30 calendar days after representation of IND before to begin any clinical tests. As it can cost hundreds of millions of dollars - and many years - to undertake the clinical tests, necessary to put a new preparation on the market, application of IND shows that the sponsor is ready to make these huge investments. Also, reaction of the investor to application of IND - the first step in long and difficult process for approval of a preparation - served the company is typically neutral.
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