The Potential Impact of the FDA Globalization Act of 2009 - ComplianceOnline (FDA Globalization Ac)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Apr 24, 2009
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Description

The FDA Globalization Act of 2009 is legislation that will amend the FD&CA, and give significant teeth to the proposed Good Importer Practices guidance. As it is estimated that > 80% of APIs are imported into the U.S., the financial and manpower impact on the Pharma industry will be significant. This presentation will review the proposed legislation and guidance, the implications of each, and suggest approaches to proactive compliance.

Venue

Additional Information

The FDA Globalization Act of 2009 is legislation that will amend the FD&CA, and give significant teeth to the proposed Good Importer Practices guidance. As it is estimated that > 80% of APIs are imported into the U.S., the financial and manpower impact on the Pharma industry will be significant. This presentation will review the proposed legislation and guidance, the implications of each, and suggest approaches to proactive compliance.