Advertising, Promotion & Medical Information

Promotional rules, labeling use, medical information, and compliance expectations

7 terms

The evidence required to support promotional claims (e.g., efficacy, superiority, safety) to avoid misleading communications.

Fair Balance

A promotion principle requiring presentation of risk information with a prominence and readability comparable to benefit information.

FDA Form 2253

US form used to submit certain promotional labeling and advertising materials to the FDA for review/record, as applicable.

Medical Information

A function/process that responds to healthcare professional or patient inquiries with accurate, balanced, and compliant information about a product.

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Advertising, Promotion & Medical Information

Promotional rules, labeling use, medical information, and compliance expectations

7 terms

Claim Substantiation

The evidence required to support promotional claims (e.g., efficacy, superiority, safety) to avoid misleading communications.

Fair Balance

A promotion principle requiring presentation of risk information with a prominence and readability comparable to benefit information.

FDA Form 2253

US form used to submit certain promotional labeling and advertising materials to the FDA for review/record, as applicable.

Medical Information

A function/process that responds to healthcare professional or patient inquiries with accurate, balanced, and compliant information about a product.

Off-Label Use

Use of an approved product in a manner not described in the approved labeling (e.g., different indication, dose, population).

Office of Prescription Drug Promotion(OPDP)

FDA office responsible for oversight of prescription drug promotional materials and enforcement of advertising and promotion requirements.

Unsolicited Request

A request for information not prompted by promotional activity (e.g., a clinician asks about an unapproved use), typically handled with compliant medical information processes.