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EMA Work Plan for GMP GDP Inspectors Group for 2016 can be accessed.....

Third party auditing and certification of excipient suppliers can assist in the development, manufacture and supply of safe and effective medicinal products.

On July 15, 2015, FDA held a public meeting to seek input on the reauthorization of the Prescription Drug User Fee Act (2002) (PDUFA). David R. Schoneker presented comments during the meeting.

IPEC-Americas Publishes Position Paper on Accelerated Stability

IPEC-Americas submits comments on the reauthorization of the Generic Drug User Fee Amendments of 2012.

In just one more year, during 2016, IPEC-Americas will mark and celebrate its 25th Anniversary! This month's Insider e-newsletter highlights the very beginning: the birth of IPEC-Americas.

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