Legal and Ethical Aspects of Experimental Drug Distribution and Retrieval

¹ Winthrop Laboratories.

The legal obligations of the sponsoring manufacturer call for careful records of distribution and retrieval of a new drug when the investigation is concluded. A similar duty is imposed upon the clinical investigator. The status of an investigational drug must continually be borne in mind: the exemption that permits its use in clinical trials is terminated upon approval of a new drug application. All materials used in clinical investigations must be accounted for by both sponsor and investigator.

Where a doctor is continuing a study after the new drug application has been approved, the investigational material should be returned to the sponsor; usually it will be replaced with commercial material. The retrieval procedures described should be carried out at the conclusion of any planned investigation. This practice helps both sponsor and investigator to keep track not only of the material but also of reports on the use of the drug.

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