55 Minute Video | Julie K. Tibbets, Alston & Bird LLP
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
Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles that will be most applicable for this session will be:
- Regulatory Affairs
- Advertising & Promotions Compliance
- Legal Counsel
- Compliance Officers
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
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Julie Tibbets is a partner in the Food, Drug & Device/FDA Group at Alston & Bird LLP. Julie focuses her practice on all aspects of product branding, advertising, and promotion, advising manufacturers and marketers of FDA-regulated products on the regulatory risks of their current product positioning or activities. Julie was selected by Super Lawyers as a 2013 Washington, D.C. "Rising Star" in the FDA area.