The FDA in a Post-Gottlieb World - Webinar Recording/Transcript

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The FDA in a Post-Gottlieb World: Gottlieb’s Accomplishments, New Policies — and a Look Ahead

The FDA’s leadership is changing and it’s time to take a look at what’s ahead for you. 

Join us for a detailed analysis about whether the changes and reforms advanced in the past two years will remain and whether it will affect your product development and approval applications.

Takeaways:

  • Policy decisions on generic drug approvals
  • Reorganization of the Office of New Drugs
  • Changes in orphan drug policy
  • New initiatives dealing with the effort to reduce drug prices
  • Further changes in FDA’s policies on advertising and promotion regulation
  • Changes in FDA standards for clinical trials

Gain an expert perspective on the Gottlieb years, the key issues addressed, regulations and guidances issued, and the way that these issues will be handled in the future.

  • Regulatory professionals
  • Quality assurance professionals
  • FDA Attorneys
  • Marketing Executives

Meet Your Presenters

Wayne L. Pines, President, Health Care, APCO Worldwide
Wayne Pines provides strategic counsel to clients facing crises or media, legislative, regulatory or marketing challenges. Mr. Pines has worked on health care and regulatory issues; litigation; product approvals; advertising issues; recalls; and congressional issues involving the regulation of pharmaceuticals, medical devices and food. Mr. Pines served 10 years in senior positions at the FDA. He was FDA’s chief of consumer education and information, chief of press relations and associate commissioner for public affairs. He was the chief media spokesman for the FDA for seven years and was the founding editor of FDA consumer magazine. 

Kevin Madagan, Partner, Reed Smith, LLP
Kevin Madigan is a health care and FDA regulatory attorney and member of the Life Sciences Health Industry Group. He advises clients across the life sciences and health care spectrum about health care and FDA regulatory issues related to the manufacturing, distribution, and sale of drugs (Rx, OTC, homeopathic), biologics, devices (Rx and OTC), and dietary supplements. His clients include suppliers, manufacturers; repackagers; wholesale and private label distributors; pharmacies (503A, 503B, nuclear); and health care providers.