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 ...

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 U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for MF-300, a first-in-class orally administered, 15-hydroxyprostaglandin ...

Please provide your email address to receive an email when new articles are posted on ... episodes and nighttime blood pressure (BP). The drug’s safety profile in this specific patient ...

AIM ImmunoTech (AIM) announced its initiation of a plan to advance Ampligen as a vaccine adjuvant for avian influenza as part of the Company’s ...

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 ...

The University of Chicago will receive up to $130 million in funding over the next 10 years as part of a new drug research ...