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OVER-THE-COUNTER (OTC) DRUGS
Regulatory Pathways
- ♦ Rx-to-OTC Switches
♦ OTC Monograph amendments
♦ Forced switch petitions
♦ Hatch-Waxman Exclusivity for OTC Switches
- ♦ Reviews – format and substantive language requirements
♦ Acceptable/unacceptable claims
- ♦ FTC actions
♦ NAD proceedings
For presentations and articles on OTC Drugs, just click here ...
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