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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
Part 1 – Drug and Biologics Advertising and Promotion 101
Marc J. Scheineson, Esq.
Partner
Alston & Bird LLP
- Overview of laws and regulations controlling the advertising, marketing, and promotion of prescription drugs and biologics
- 21 CFR Sections 202.1, 352(n), 314.81(b)(3); Section 352(n) of FD&CA
- Guidance documents
- Exploring the role of the Office of Prescription Drug Promotion (OPDP)
- What duties and responsibilities is DDMAC charged with?
- What are its enforcement capabilities and jurisdiction?
- Identifying the role of the FTC in the advertising and promotion of drugs
- SEC?
- Advertising requirements for prescription v. nonprescription products
- Reviewing the steps which OPDP takes for the review of launch campaigns and promotional materials
- Overview of the promotional materials submission and review process
- What constitutes a launch?
- What defines an advertisement?
- What information must a drug advertisement include?
- Exploring the role of the label in advertising