Advertising Drugs and Devices: Keys to FDA and FTC Compliance

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Advertising Drugs and Devices
Keys to FDA and FTC Compliance

The FDA and FTC tightly control advertising of medical products, and drug and device companies need to know where they draw the line between what language is permissible and what is not.

Advertising Drugs and Devices: Keys to FDA and FTC Compliance, a hands-on guide, lays out the advertising landscape as the government sees it — regulations, requirements, expectations — and shows you the right road to take to compliance.

You will learn:

  • How the FDA evaluates and approves advertising submissions

  • The FTC’s primary concerns in controlling medical product advertising

  • How to submit advertising for review and approval

  • How to draft the required “brief summary” of side effects

  • When to use the alternative “major statement of drug risk”

  • How to establish the truthfulness of advertising language

  • How to substantiate claims made in advertising

  • Dealing with interactive promotional media that allow for real-time communication

  • Postmarket requirements for advertising that can’t be reviewed in advance

The Advertising Drugs and Devices will help you understand how to keep your advertising efforts inside the lines of compliance to avoid federal action and/or private liability.

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PDF Edition — $177

Who Will Benefit

  • Corporate counsel
  • Regulatory affairs
  • Quality unit
  • Marketing department

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