Legal, Regulatory and Compliance Forum on Over the Counter Drugs

Loeb & Loeb LLP is pleased to announce that partner David G. Mallen will be speaking at the American Conference Institute's 3rd Annual "Legal, Regulatory and Compliance forum on Over the Counter Drugs" on "Harmonizing Advertising, Labeling, and Social Media Practicesfor OTCs to Comply with Both the FTC and FDA Regulations".

From the conference website:
Earlier this year, the FDA announced that the OTC Drug Monograph System and OTC Drug Review Process will be overhauled to meet the current needs of OTC manufacturers. The modernization of the Monograph System will revolutionize the OTC drug industry and change the way that over the counter drugs and consumer healthcare products reach the shelves. Billions of dollars are at stake as the OTC drug industry anxiously awaits the FDA’s proposals and ponders how this will impact business practices and profits.
ACI has designed this unique program to address the needs of the OTC drug industry. Legal and regulatory experts in the OTC space will provide you with the critical information you now need to:

• Predict how the FDA will implement significant changes to the Monograph System, thereby changing how OTC drugs get approved
• Extract the fine points of the NSURE Initiative and track the results of increasing access to nonprescription drugs
• Overcome legal and regulatory hurdles associated with novel Rx-to-OTC switches
• Reposition your company in light of the recent M&A activity among OTC drug companies
• Develop social media, advertising, and trademark strategies for OTC drugs while identifying the legal pitfalls
• Comprehend the importance of patent strategies in the OTC space
• Appreciate the unique challenges associated with the homeopathic pharmacopeia
• Understand the implementation of more stringent regulations for pediatric OTCs
• Develop a global strategy for over the counter drugs

This is the only event where industry insiders will meet to discuss the legal and regulatory policies specifically impacting enforcement activity and related civil class action litigation in the OTC space. Faculty members will help you design strategies for establishing recall protocols, developing AER and cGMP best practices, which will help you avoid enforcement actions and class action suits.