The investigator must maintain control of an investigational study drug. An investigational drug may only be administered to subjects under the personal supervision of the investigator or a designated ...

Pharmaceutical companies often have a limited supply of an investigational drug, which may not be sufficient to meet the demand from both clinical trials and EAPs. 4 This raises difficult ...

World Courier is pleased to announce the opening of its newest purpose-built, ISO-certified, GMP-compliant investigational drug storage depot in ...

In these cases, omissions or errors in the medication order may lead to dispensing from the wrong drug supply at the time orders are filled. Lastly, in the investigational study setting ...

An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. The term ...

By Joachim Leube, Bayer HealthCare Manufacturing, Italy New options of therapy are needed for a considerable number of diseases.

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application ...

today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug application (IND) to initiate a clinical study of the company’s investigational UKidney ...