Pharmaceutical Development Group

Pharmaceutical Consultant and FDA Regulatory Strategist

Drug Labeling Specialist on New Pregnancy Labeling Rules

Pharmaceutical Development Group

On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the demise of pregnancy categories (A, B, C, D, X), which have been in use since 1979.

The new rule ushers in what is expected to be an era of unprecedented inclusion with regard to descriptive risk and benefit information.

The US Food and Drug Administration (FDA) said: "a narrative structure for pregnancy labeling, rather than a category system, is best able to capture and convey the potential risks of drug exposure based on animal or human data, or both".

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