Top Tips for Dealing with the FDA - Webinar Recording/Transcript

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Top Tips for Dealing with the FDA: How to Engage, Respond to Inquiries and Avoid Enforcement Actions

The FDA is an inescapable presence in your life. It can be supportive and helpful one day, then turn on a dime and make life quite difficult indeed.

But you have a say in the matter. You can control this all-important relationship to your advantage.

Here’s how.

Regardless of which party makes the first move — you or the agency — this session will ready you with best practices, moves and countermoves:

  • How to respond to a Form 483
  • How to avoid a warning letter
  • How to ask sensitive questions: Implementation of particular laws or regulations
  • Alternatives to direct engagement
  • Safeguarding sensitive commercial information
  • What to do when your competitor isn’t complying with FDA requirements
  • Identifying the correct agency point of contact
  • Resources available to you
  • And much more!

The FDA is an institution, true. But it’s also an organization staffed with human beings with their own agendas, open or hidden. Managing them shouldn’t be all that different from managing staff. Why not learn better ways to do so ... now!

  • Regulatory affairs/compliance
  • Quality/GMP
  • General/corporate counsel
  • Outside attorneys

Will Woodlee Esq. is a partner at Kleinfeld Kaplan & Becker LLP, a Washington law firm specializing in FDA representation. His practice focuses on advocating on behalf of regulated entities, and he has broad experience in dealing with the agency in both proactive and defensive contexts. Super Lawyers has named him a 2015-2018 “Rising Star” of food and drug practice in Washington.