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Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings

Published: September 2007 |  Pages: 67 |  Price:  $337  | ISBN:  978-1-60004-164-8  | Table of Contents

Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings, a management report from FDAnews, maps out every aspect of an import hold, including how to fix problems before they land your shipment in trouble with FDA and customs officials, the best way to train your team to use the right (and avoid the wrong) approaches with agency personnel and when to activate a rapid-response strategy that gets your imports off hold and into use fast.

No more guesswork or mistakes! This management report brings you real-world guidance from an attorney who has successfully negotiated the release of hundreds of FDA-regulated shipments into the U.S.

Order today and arm yourself with the know-how to:

  • Anticipate what FDA and customs officials will look for when examining your shipments
  • Decipher a Notice of FDA Action and activate an effective defense
  • Negotiate hold releases — including when to bring in outside help
  • Prepare for the informal hearing to boost chances of a positive outcome
  • Apply the five most successful strategies for challenging agency findings
  • Avoid five common strategies that can backfire — and cost you millions
  • Communicate with agency personnel using these six techniques — without triggering lethal delays and misunderstandings
  • Comply with documentation requirements so paperwork sails through

Buy Now!
Negotiating an FDA Import Hold Crisis: Strategies for Challenging FDA Findings can save you time, penalties and millions of dollars in profits.  Don’t risk your next shipment — order your management report now. Available in print or PDF format for $337 each.

Interested in purchasing more than one print copy?
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ISBN: 978-1-60004-164-8 ISBN: 978-1-60004-165-5
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