Module 6

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OTC DRUG REVIEW…

• Following on from the DESI review (1962 onwards)… ● OTC drug review – initiated 1972 ● Definitions established: ❑ GENERAL RECOGNITION OF SAFETY AND EFFECTIVENESS ❑ GRASE

● MONOGRAPHS established

The Organisation for Professionals in Regulatory Affairs

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OTC Drug Monograph

Rx NDA

OTC NDA

 OTC approval by means of an NDA: ▪ Start with Rx status

▪ Gain experience in the market ▪ Safety appropriate for OTC use?

▪ Prepare for SWITCH application ▪ Additional clinical studies ▪ OTC use study ▪ Labeling comprehension study

The Organisation for Professionals in Regulatory Affairs

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