U.S. Food and Drug Administration Regulations


Expanded Access to Investigational Drugs for Treatment Use

FDA requirements for the use of investigational new drugs and approved drugs where availability is limited by a risk evaluation and mitigation strategy when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition. The goal is to facilitate the availability of such drugs to patients with serious diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient’s disease or condition.

21 C.F.R. §§ 312.300 -312.320

 

Financial Disclosure By Clinical Investigators

FDA regulations that require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsors and the investigators regarding a product in a study or a sponsor of a study.

21 C.F.R. § 54

 

Informing Investigators

Sponsor’s responsibility to keep investigators informed of new observations discovered by or reported to the sponsor on a drug, particularly with respect to adverse effects and safe use.

C.F.R. 312.55

 

Unanticipated Events for Drugs

Sponsor’s responsibility to select qualified investigators  providing them with the information they need to conduct an investigation properly

21 C.F.R. 312.50

 

Humanitarian Use Device

FDA procedures and requirements governing the discovery and use of devices intended to benefit patients in the treatment or diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year.

21 C.F.R. Part 814 Subpart H

 

Investigational Device Exemptions

FDA procedures and requirements governing the use of investigational devices, including procedures and requirements for the submission to, and review by, the FDA.

21 C.F.R. 812

 

Investigational New Drug Application

FDA procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by the FDA.

21 C.F.R. Part 312

 

U.S. Food and Drug Administration (FDA)

The United States Food and Drug Administration (FDA) evaluates clinical studies submitted in marketing applications, required by law, for new human drugs and biological products and marketing applications and reclassification petitions for medical devices. Please see the links below for the most commonly accessed FDA information.

Additional FDA links for clinical trial related information and documents have been provided.  You will find these FDA links helpful as you prepare, manage, and close your trial.