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Tapes Library
Prescription Drug Marketing: Promotional Interactions with Healthcare Providers
Speaker:

Richard Wood, Bell, Boyd & Lloyd, Chicago

Wood counsels clients in all aspects of the FDA's regulation of foods, drugs, medical devices, biologics and dietary supplements. He has also represented clients before the USDA, the Drug Enforcement Administration and the Environmental Protection Agency. In particular, he has advised clients on food and drug advertising issues and compliance with California's Proposition 65 relating to product health warnings.

Date of Briefing:
July 30, 2002
Approximate length:
One hour
Description:
Wood discusses the rules that apply when various promotional approaches are made to healthcare providers:
  • Overview of Relevant FDA Rules that Apply to Promotional Activities
  • Face-to-Face Promotional Interactions
  • Distribution of Medical Journal Reprints
  • The Funding and Use of Educational Symposia
  • The Use of Health Care Organizations to Promote Products
  • The AMA Restrictions on Promotional Activities
  • A review of recent FDA enforcement activities involving promotions and health care providers.
 
Price:
$325 Tape
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Tapes Library

Prescription Drug Marketing: Developing Compliant Web-based Rx Drug Promotions
Speaker:
Christopher Brown, Arent Fox, Washington, DC

Brown, an associate in Arent Fox's Food and Drug Practice Group, represents clients before the FDA regarding labeling, health claims, structure/function claims, premarket approval applications, investigational new drug applications, regulations governing clinical trials, investigational device exemptions, regulations covering clinical trials and new dietary ingredient submissions.
Date of Briefing:
July 24, 2002
Approximate length:
One hour
Description:
Brown provides insight on leveraging one of the fastest-growing channels for Rx drug marketing. The session offers:
  • Overview of FDA drug regulation
  • Overview of FDA Regulation of Drug Promotion and Marketing
  • FDA Policy Statements and Guidances Regarding Internet Drug Promotion
  • The Effect of FDAMA and Recent Court Decisions on Internet Drug Promotion
  • Unresolved Issues; Status of Internet-specific FDA Guidance
  • Actions FDA Has Taken Against Internet Drug Promotion
  • Overview of FTC Regulations on Advertising
  • Current FTC Initiatives and Actions on Drug Promotion on the Internet.
Price:
$325 Tape
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Tapes Library
Prescription Drug Marketing: Off-label Promotions: Complying with FDA and SEC
Speaker:
Sam Kazman, General Counsel, Competitive Enterprise Institute.Mr. Kazman heads a project at CEI that focuses on raising public awareness of the often hidden costs of government overregulation - the lives lost, for example, when the Food and Drug Administration delays new medical drugs and devices.Mr. Kazman's writings have been featured in The Washington Post, The Wall Street Journal and USA Today. He has testified at a number of congressional hearings and has appeared on such shows as Crossfire, Court TV, Good Morning America and the NewsHour with Jim Lehrer.
Date of Briefing:
June 12 , 2002
Approximate length:
One hour
Description:

This session examines FDA's susceptibility to "deadly over-caution;" the long-term viability of Pediatric Rule reform; two studies on the speed of new drug approvals; the case against FDA's Pediatric Rule; and public sentiment toward the pharmaceutical industry.

Price:
$325 Tape
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Tapes Library
Prescription Drug Marketing: BUY ALL THREE AND SAVE $150! 
Details:
Purchase the complete Prescription Drug Marketing series audiocassettes and save $150.  Series includes Off-label Promotions: Complying with FDA and the Securities and Exchange Commission; Developing Compliant Web-based Rx Drug Promotions; and Promotional Interactions with Healthcare Providers - all for just $825.  $975 if purchased separately. 
Price:
$825
rApproximate length:
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