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Home > Newsletters > The GMP Letter > Pilot Would Reduce Audit Frequency Using Harmonized Regulations

The GMP Letter

April 2012

Pilot Would Reduce Audit Frequency Using Harmonized Regulations

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.

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Philippines Embraces Harmonized Postmarketing Alert System Device Groups Push to Include Single Audit in TTIP; Negotiations May Start by Summer Device Groups Push to Include Single Audit in TTIP; Negotiations May Start by Summer IMDRF Draft Standards Fill Blanks on Unannounced Audits, Auditor Conduct

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