FDAnews Drug Daily Bulletin

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

July 11, 2019

The FDA flagged the importance of abuse and dependence labeling for prescription drugs and biologics in a new draft guidance — calling them key factors in the agency’s drug reviews.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