sponsor requirements contained in 21 CFR 312 for research with Investigational New Drugs (INDs). Other FDA regulations for sponsors include, but are not limited to, 21 CFR Parts 11, 54, 210, and 211.

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 ...

Right now they’re evaluating 5 different investigational drugs for squamous cell lung cancer in the same protocol. And the plan is that over time, more investigational agents can be brought into ...

Next up: the investigational new drug enabling study, a crucial step before applying for clinical trials. Kim’s exploring how these same compounds could stop other diseases. So far, they’ve proven ...

Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...

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 ...

The trial will evaluate the safety and effectiveness of a next-generation vaccine administered through a nasal spray or ...

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 ...