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 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.
This paper describes the position of IPEC-Americas on implementation of the NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
The Coalition for Rational Implementation of the USP Elemental Impurities Requirements provided comments to USP which are related to the sample preparation methods in USP General Chapter <233>.
Several countries are requiring excipient suppliers to supply Certificates before they will allow the excipients to be imported into the country.