The FDA flagged the importance of abuse and dependence labeling for prescription drugs and biologics in a new draft guidance — calling them key factors in the agency’s drug reviews.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