IPEC-Americas has prepared a position paper on this issue to assist MAHs in Europe in meeting their risk assessment obligations as defined in the EU Guidelines.
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