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The Synthetic Amorphous Silica and Silicate Industry Association recently published a press release that clarifies the difference between Crystalline Silica and Synthetic Amorphous Silica.

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.

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