Regulatory Terms Starting With F

4 terms in the F index.

• Fast Track Designation (Fast Track)

  Fast Track Designation is an FDA status, granted on sponsor request, that expedites development and review of a drug for a serious or life-threatening condition demonstrating potential to address an unmet medical need.

• FDA (Food and Drug Administration)

  FDA is the United States federal agency within the Department of Health and Human Services that authorizes drugs, biologics, and medical devices before marketing and regulates the safety and labeling of foods and cosmetics.

• FDA Form 483 (Form 483)

  FDA Form 483 is the written list of inspectional observations an FDA investigator hands to facility management at the close of an inspection, recording conditions that may violate the FD&C Act without constituting a final agency determination.

• First-in-Human Study (FIH)

  A first-in-human study is the first administration of an investigational drug or biologic to human subjects, run under an IND in effect, to establish tolerability, pharmacokinetics, and a safe dose range before efficacy is tested.