FDA Legal Services for OTC Drugs

FDACounsel.com -- Legal Services -- for the life of a Life Sciences company

OVER-THE-COUNTER (OTC) DRUGS SERVICES

Regulatory Pathways
   ♦ Rx-to-OTC Switches
   ♦ OTC Monograph amendments
   ♦ Forced switch petitions
   ♦ Hatch-Waxman Exclusivity for OTC Switches
Labeling
   ♦ Reviews – format and substantive language requirements
   ♦ Acceptable/unacceptable claims
Promotion & Advertising
   ♦ FTC actions
   ♦ NAD proceedings

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