Reducing Risks & Increasing Effectiveness of Advertising & Promotion through Advertising & Promotion Regulatory Oversight, Interpreting & Implementing FDA Guidance on Medical Product Communications That Are Consistent With the FDA-Required Labeling and Guidance on Drug & Device Manufacturer Communications With Payors, Formulary Committees & Similar Entities
In the highly competitive life science environment, where companies seek to drive increased revenue through a wide range of advertising and marketing efforts including direct-to-consumer advertising, outreach at conventions and expos, medical education, social media, press releases, and more, advertising and promotion regulatory affairs executives face numerous challenges in the effort to remain compliant with FDA regulations and guidances. Recent FDA policy updates including the Medical Product Communications That Are Consistent With the FDA-Required Labeling guidance and the Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities guidance have added additional layers of uncertainty and given many advertising and promotion regulatory affairs professionals reason for caution, as the level of FDA’s enforcement of these guidances remains unclear.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
312.955.0424 | email@example.com