Biotech & Regulatory

Biotech regulatory basics: the FDA, the BLA and IND applications, clinical phases, approval and labeling, orphan-drug status, and the PDUFA action dates that set the clock.

Key terms & definitions

15 terms in this pack

APPROVAL

The regulatory decision that would unlock revenue

BIOLOGIC

A drug made from living systems, like an antibody

BLA

Biologics License Application filed to win approval (acronym)

CLINICAL

___ trials: the studies that test a drug in humans

FDA

The agency whose approval decision your company awaits (acronym)

IND

Investigational New Drug application to begin trials (acronym)

INDICATION

The specific disease a drug is approved to treat

LABEL

The FDA-approved indications and instructions for a drug

MANUFACTURING

The 'M' in CDMO; making the drug at scale

ORPHAN

___ drug: designation for a therapy targeting a rare disease

PATENT

Exclusive right protecting a drug for a period

PDUFA

Act that sets the FDA's target action date for an application (acronym)

PHASE

A stage of a clinical trial, numbered 1 through 3

PIPELINE

A company's portfolio of drugs in development

PREREVENUE

Stage of a company with no product sales yet