Mastering the FDA's Import Rules

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Mastering the FDA's
Import Rules

U.S. authorities are holding imports more than ever before, particularly at ports that have a history of holding products, and imports from India.

This management report will tell you how to develop a top-notch import compliance program that will keep you in the “safe zone” when it comes to your dealings with the FDA and Customs. You'll gain a clear understanding of the FDA’s expectations and qualifications and Customs’ operational processes.

You'll also learn:

  • The inside scoop from a former FDA import official on the FDA's latest priorities and expectations
  • What to do to minimize your risk of delays, detentions and refusals
  • How to work closely with suppliers, contract manufacturers and labelers to significantly reduce your hold times
  • How to conduct a gap analysis to identify weaknesses in your existing compliance program
  • How the FDA operates its import process and uses its main tool — PREDICT
  • The importance of proper declarations and other good importer practices to ensure compliance with FDA regulations

Don't take the chance of having your imports held at Customs for reasons that aren't obvious or clear to you.

It's your chance to save your company time … money … and tiresome headaches.


PDF Edition

Available Format

PDF Edition — $397

Table of Contents

  • Introduction
  • Think Like the FDA to Avoid and Manage Import Holds
  • Top Issues that Can Cause Import Holds
  • The Scope of FDA Authority
  • And More …

View the entire TOC

Who Will Benefit

  • Drug and device company executives
  • Import/export officers
  • Regulatory affairs officers
  • Supply chain managers
  • Manufacturing directors and supervisors
  • Legal affairs officers

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