Regulatory glossary

Plain explanations of the terms life sciences teams work with every day. Written by people who read the source documents, and updated when the guidance moves.

• What Is a Complete Response Letter? FDA CRLs Explained

  FDA's decision not to approve an application in its present form. What a CRL contains, your three options, and the one-year clock that follows.

• Biologics License Application (BLA): What It Is and How to File One

  The application to market a biological product in the US, under section 351 of the PHS Act. What goes in it, how it differs from an NDA, and the timelines.

• Batch Manufacturing Record (BMR): What It Is and What Goes In It

  A BMR is the executed record of one batch. What 21 CFR 211.188 requires in it, how it differs from the master record, and where BMRs fail inspection.

• Structured Product Labeling (SPL): The FDA XML Standard, Explained

  SPL is the HL7 XML format FDA requires for drug labeling, listing and establishment registration. What it is, what goes in it, and how it reaches DailyMed.

• What Is GxP? The Good Practice Regulations, Explained

  The umbrella term for the good practice regulations in life sciences: GMP, GLP, GCP and the rest. What each covers, who enforces it, and what compliance means.

• 21 CFR Part 11: Electronic Records and Signatures, Explained

  FDA's conditions for treating electronic records and signatures as trustworthy. What it covers, what a predicate rule is, and where enforcement discretion applies.