Healthy Skepticism Library item: 8469

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Publication type: Journal Article

Prescription drugs; revocation of final guideline patient package inserts and withdrawal of draft guideline patient package inserts--Food and Drug Administration.
Fed Regist 1982 Sep 7; 47:(173):39249-50

Abstract:

A notice revoking the FDA’s final guideline patient package inserts (PPI’s) for 5 classes of prescription drugs and withdrawing the draft guideline PPI’s for 5 other drugs is presented. The revocation of the draft and final PPI guidelines, which describe how manufacturers might comply with the regulations with respect to the affected classes of drugs, is effective on September 1, 1982.

Keywords:
Drug Labeling/standards* Prescriptions, Drug/standards* United States United States Food and Drug Administration