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Discussing Trends in OPDP Enforcement Letters to Avoid Infractions



 
Our Price: $395.00

Product Code: WB-7080
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About the Product
Includes 55 minute Windows Media Video File and PowerPoint presentations for immediate download.

According to a recent Office of Prescription Drug Promotion (OPDP) webinar, the FDA stated that it does not see any new non-compliance trends among pharmaceutical advertising at this time; but does commonly observe overstatement of efficacy, minimization/omission of risk, unsubstantiated claims as well as pre-approval promotions. Pharmaceutical executives are looking to uncover and evaluate these and other reoccurring trends among recent warning letters, in order to create and maintain a proactive approach in meeting regulatory requirements. Offending drug companies must engage in corrective advertising; as failure to correct violations cited in a warning letter can result in FDA regulatory action, including seizure or injunction. Attendees will take away from this session:
  • A delineation between an untitled letter and a warning letter
  • Recognition & dialogue regarding infamous citations
  • Unique strategies utilized to avoid warning letters

Speaker:

Julie Tibbets
Partner
Alston & Bird LLP


Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs
  • Advertising & Promotions Compliance
  • Legal Counsel
  • Compliance Officers

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