Services -- OTC Drugs & Cosmetics

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

Promotion & Advertising
♦ FTC actions
♦ NAD proceedings 


 Labels and Labeling Reviews
♦ Evaluating "cosmetic" vs. "drug" claims
♦ Ingredient assessments

Handling Enforcement Activity

Adverse Event Handling

Registration and Listing Requirements 

For presentations and articles on OTC Drugs and Cosmetics, ...