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Articles by John Y. Lee

John Y. Lee


John Y. Lee is executive director at Pharmaceutical Compliance Associates, and a former FDA investigator at New Jersey District, 523 No. Bay Avenue, No. Massapequa, NY 11758, tel: 516.752.0998, fax: 516.752.8931, e-mail: jyleepca@aol.com.

Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations
March 2, 2008

There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.

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