Services -- OTC Drugs & Cosmetics

OTC Drugs

 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 

Cosmetics

 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, ...