Regulatory Terms Starting With B

Batch Record (BR)

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

Bioequivalence

Bioequivalence helps teams standardize terminology and improve decision traceability.

Biologics License Application (BLA)

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

Biosimilar

Biosimilar is a recurring concept across regulatory planning, compliance operations, and global submissions.

Breakthrough Therapy Designation (BTD)

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

Bridging STUDY

Bridging STUDY supports cross-functional regulatory execution across quality, clinical, and safety teams.