FDAnews Announces -- OTC Regulation: Latest Developments and Best Practices Webinar, March 18, 2019

What's going on in the OTC arena? Webinar discusses the latest developments and best practices.

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FDAnews

Mar 06, 2019, 00:00 ET

FALLS CHURCH, Va., March 6, 2019 /PRNewswire-PRWeb/ -- OTC Regulation
Latest Developments and Best Practices
**An FDAnews Webinar**
Monday, March 18, 2019, 1:30 p.m. - 3:00 p.m. EDT
http://www.fdanews.com/otcregulation

There are significant new developments in OTC products including OTC monograph reform legislation, draft guidance on innovation in OTC products, recent enforcement actions, and user fees.

Christine Kirk — an associate in the Food and Drug Group of Arnall Golden Gregory's healthcare practice — will discuss recent developments in OTC regulation and enforcement as well as key compliance topics. Attendees will learn about:

  • Significant OTC monograph reform legislation that is currently pending in Congress (H.R. 269) which would:
  • Establish an OTC user fee program
  • Change the way that monographs are issued
  • Provide a pathway for limited exclusivity for certain OTC products
  • 2018 draft guidance on innovation in the OTC space published as Innovative Approaches for Nonprescription Drug Products which includes:
  • The development of labeling in addition to the DFL
  • Implementation of additional conditions so that consumers appropriately self-select and use the product
  • Recent OTC-related enforcement actions
  • Common areas of confusion — such as marketing claims and labeling requirements
  • Key compliance issues and resources

Attendees will come away with a deeper understanding of the recent developments in the OTC area.

Meet Your Presenter:
Christine Kirk is an associate in the Food and Drug Group within Arnall Golden Gregory's Healthcare Practice, and focuses her regulatory compliance practice on food, drug, and device law. Ms. Kirk has several years of experience with FDA, where she worked in CDER's Office of Regulatory Policy (ORP). While at FDA, Ms. Kirk worked on a wide variety of matters, including regulations, guidance, citizen petitions, and policy development. Ms. Kirk also has experience in reviewing comments on proposed regulations and guidance.

Who Will Benefit:

  • Regulatory
  • Legal
  • Compliance
  • Advertising and promotion

Webinar Details:
OTC Regulation
Latest Developments and Best Practices
**An FDAnews Webinar**
Monday, March 18, 2019, 1:30 p.m. - 3:00 p.m. EDT
http://www.fdanews.com/otcregulation

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/otcregulation
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.

SOURCE FDAnews

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