Regulatory Terms Starting With B

Basket Trial (Basket Trial)

A clinical trial design that tests one investigational therapy across multiple indications or tumor types sharing a common molecular target or biomarker.

Batch Record (BR)

A comprehensive document containing all information and instructions for manufacturing a specific batch of drug product.

Biocompatibility (Biocompatibility)

The ability of a medical device material to perform its intended function without causing adverse biological response in contact with tissue, blood, or other body fluids.

Bioequivalence (BE)

The absence of a significant difference in the rate and extent to which the active ingredient in two pharmaceutically equivalent products becomes available at the site of drug action.

Biologics License Application (BLA)

A submission to the FDA requesting approval to market a biological product in the United States.

Bioresearch Monitoring (BIMO)

FDA's program that inspects clinical investigators, sponsors, IRBs, and nonclinical laboratories to verify compliance with applicable regulations.

Biosimilar (Biosimilar)

A biological product highly similar to an FDA-approved reference biologic with no clinically meaningful differences in safety, purity, and potency.

Biosimilar Interchangeability (Interchangeability)

A higher regulatory designation than biosimilarity, requiring demonstration that a biosimilar can be substituted for its reference product without intervention from the prescribing physician.

Blinding (Blinding)

A clinical trial design technique where participants, investigators, or both are prevented from knowing which treatment each subject is receiving.

Boxed Warning (Black Box Warning)

The strongest warning that FDA requires in prescription drug labeling, highlighting serious or life-threatening risks.

Breakthrough Therapy Designation (BTD)

An FDA designation for drugs showing substantial improvement over existing treatments for serious conditions.

Bridging Study (Bridging Study)

A clinical study conducted to allow extrapolation of efficacy and safety data from one region or population to another.