![]() Section 312.23 outlines the information needed for a commercially sponsored IND for a new molecular entity. Sponsors are expected to exercise considerable discretion, however, regarding the content of information submitted in each section, depending upon the kind of drug being studied and the nature of the available information. (d ) The IND format set forth in § 312.23 should be followed routinely by sponsors in the interest of fostering an efficient review of applications. Individual patients, including for emergency use. Requirements for all expanded access uses. Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.Īctive monitoring of conduct and evaluation of clinical trials.įoreign clinical studies not conducted under an IND.Īvailability for public disclosure of data and information in an IND.ĭrugs for Investigational Use in Laboratory Research Animals or In Vitro Testsĭrugs for investigational use in laboratory research animals or in vitro tests.Įxpanded Access to Investigational Drugs for Treatment Use Inspection of investigator's records and reports.ĭisqualification of a clinical investigator.ĭrugs Intended to Treat Life-threatening and Severely-debilitating Illnesses ![]() Investigator recordkeeping and record retention. General responsibilities of investigators. Inspection of sponsor's records and reports.ĭisposition of unused supply of investigational drug. Transfer of obligations to a contract research organization.Įmergency research under § 50.24 of this chapter. Responsibilities of Sponsors and Investigators General requirements for use of an investigational new drug in a clinical investigation.Ĭlinical holds and requests for modification. General principles of the IND submission. Investigational New Drug Application (IND) Charging for investigational drugs under an IND.
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