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Latest Developments and Keys to Successful Compliance with FDA Regulations and Guidance Webinar Dec. 2, 2020

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WCG FDAnews

WCG FDAnews


FALLS CHURCH, Va. (PRWEB)

Advertising and Promotion Compliance:

Latest Developments and Keys to Successful Compliance with FDA Regulations and Guidance

An FDAnews Webinar

Wednesday, Dec. 2, 2020, 11:00 a.m.-12:30 p.m. EST

https://www.fdanews.com/adpromocompliance

Promotional activities can be magnets for warning letters or untitled letters.

How can one successfully comply with the FDA’s complex advertising and promotion guidelines?

Join Covington & Burling LLP’s Stefanie A. Doebler, a Partner, and Christopher Hanson, Special Counsel, for an introduction to advertising and promotion principles, including requirements for promotion (incorporating claims substantiation, fair balance and off-label promotion) and key differences between drug and device promotion.

They will use case studies from recent enforcements to explain the most important risk areas, including:


  • Key statutory definitions used in the Federal Food, Drug and Cosmetic Act (FD&C Act), such as misbranded, labeling and false and misleading

  • The primary requirements for advertising and promotion set forth in the FD&C Act and implementing regulations

  • The FDA’s recent guidance on promotion consistent with the approved labeling described in its 2019 guidance, “Medical Product Communications That Are Consistent With the FDA-Required Labeling”

  • The scope of the prohibition on preapproval promotion, 21 CFR 312.7, 812.7

  • The difference between promotion and disease awareness communications, described in FDA’s draft guidance, “‘Help-Seeking’ and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms”

What one doesn’t know about drug and device advertising and promotion will hurt you. Arm oneself against violations with this webinar.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally to learn about our special multisite discount.

Webinar Details:

Advertising and Promotion Compliance:

Latest Developments and Keys to Successful Compliance with FDA Regulations and Guidance

An FDAnews Webinar

Wednesday, Dec. 2, 2020, 11:00 a.m.-12:30 p.m. EST

https://www.fdanews.com/adpromocompliance

Tuition:

$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/adpromocompliance

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

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