Regulatory Terms Starting With B

12 terms in the B index.

• Basket Trial (Basket Trial)

  A basket trial is a master-protocol design that enrolls patients into one study by shared molecular target rather than by disease, testing a single therapy across multiple histologies as separate, independently analyzed cohorts.

• Batch Record (BR)

  A batch record is the controlled document that both instructs and evidences the manufacture of a single batch of drug product, capturing actual materials, equipment, parameters, yields, deviations, and operator signatures step by step.

• BIMO (Bioresearch Monitoring)

  BIMO is FDA's inspection program for the entities that generate research data, covering clinical investigators, sponsors, CROs, IRBs and nonclinical laboratories, and auditing study conduct and data integrity rather than manufacturing.

• Biocompatibility (Biocompatibility)

  Biocompatibility is the property of a finished medical device to contact tissue, blood, or bone without provoking an unacceptable adverse biological response, evaluated for a defined contact category and duration rather than material by material.

• Bioequivalence (BE)

  Bioequivalence is the regulatory standard requiring a test product to deliver the same rate and extent of active-ingredient exposure as its comparator, unlike pharmaceutical equivalence, which compares only composition, strength, and dosage form.

• Biologics License Application (BLA)

  A Biologics License Application (BLA) is the marketing application a manufacturer submits to obtain an FDA license under section 351 of the Public Health Service Act, granted on a demonstration that the biological product is safe, pure, and potent.

• Biosimilar (Biosimilar)

  A biosimilar is a biological product licensed under section 351(k) of the Public Health Service Act as highly similar to an existing reference product, with no clinically meaningful differences in safety, purity, and potency.

• Biosimilar Interchangeability (Interchangeability)

  Biosimilar interchangeability is a statutory FDA determination, one tier above biosimilarity, that a biosimilar produces the same clinical result as its reference product in any given patient and may be substituted without the prescriber's intervention.

• Black Box Warning (Boxed Warning)

  Black Box Warning is FDA's most serious prescription drug labeling warning, a bordered box at the start of the prescribing information reserved for contraindications or serious warnings that may lead to death or serious injury.

• Blinding (Blinding)

  Blinding is the bias-control measure in a clinical trial that conceals treatment assignment from subjects, investigators, or analysts, distinct from randomisation, which determines how subjects are assigned rather than who knows the assignment.

• Breakthrough Therapy Designation (BTD)

  Breakthrough Therapy Designation is an FDA expedited-development status granted when preliminary clinical evidence indicates a drug may substantially improve on existing therapies for a serious or life-threatening condition on a clinically significant endpoint.

• Bridging Study (Bridging Study)

  A bridging study is a clinical study run in the region where approval is sought that generates the pharmacodynamic, pharmacokinetic, or clinical data needed to extrapolate foreign pivotal trial results to that region's population.