Guidelines for CGMP Clearance of Foreign Drug Makers

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Title Supreme Court: Guidelines for CGMP Clearance of Foreign Drug Makers

Law: Fda Circular No. 2014-016

Decision Date: May 30, 2014

FDA Circular No. 2014-016 establishes guidelines for ensuring compliance with current Good Manufacturing Practices (cGMP) for foreign drug manufacturers, requiring them to obtain GMP clearance from the FDA prior to product registration and outlining the responsibilities of various FDA offices in the evaluation and inspection process.

administrative law

good manufacturing

practice

END