Healthy Skepticism Library item: 9142

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Wechsler J.
Washington report: SUPAC vs MedGuide: FDA ups and downs
Pharmaceutical Technology Europe 1996 May; 8:16, 18, 20

Abstract:

Differences of opinions regarding new initiatives for future regulations between the pharmaceutical manufacturers and the U.S. Food and Drug Administration (FDA) are discussed, including the opposition by manufacturers and pharmacists to issues concerning MedGuide, FDA’s Medication Guide labeling proposal to regulate written prescription drug information dispensed to patients. The rationale behind Scale-Up and Post-Approval Changes (SUPAC) policy for immediate release (IR) solid oral dosage forms produced by the Center for Drug Evaluation and Research (CDER) at the FDA for immediate release (SUPAC IR) solid oral dosage forms is also discussed. The FDA’s initiative to revise regulations for its SUPAC IR is now being implemented by the agency and in general has found approval among manufacturers.