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Monthly Archives: November 2019

What the Revised FDA CDER SSM Really Means

Posted on November 15, 2019 by

Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…

Posted in API synthesis, APIs, audit, FDA, outsourcing, Quality, regulatory, supply chain | Tagged , , , , | Comments Off on What the Revised FDA CDER SSM Really Means

Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement

Posted on November 4, 2019 by

In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…

Posted in agreement, APIs, Contract Manufacturing, FDA, regulatory | Tagged , , | Comments Off on Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement