FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Calls for ‘Clear, Concise’ Abuse and Dependence Labeling

July 11, 2019
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The FDA flagged the importance of abuse and dependence labeling for prescription drugs and biologics in a new draft guidance — calling them key factors in the agency’s drug reviews.

Sponsors should include clear, concise information on the product’s potential for abuse, the signs and symptoms of withdrawal, and any abuse-deterrent properties, the agency said.

“This is one of the key factors in our evaluation of a drug’s benefits and risks when we’re considering approval and remains part of our ongoing monitoring once a drug is approved,” said acting Commissioner Ned Sharpless and CDER Director Janet Woodcock in a joint statement.

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