GDUFA - News

The PCI team never stops innovating. Stay informed about our latest achievements.

What Sponsors Should Know About DMF Filings

Tags: Blog | DMFs | FDA | GDUFA

Posted June 8, 2020
Avoiding FDA Drug Rescissions: Sponsors Seek CDMOs With Strong Regulatory Track Records

Tags: API Manufacturing | Blog | FDA | GDUFA

Posted February 24, 2020
BPTF Testifies Before House Committee on Energy & Commerce About the Pharmaceutical Supply Chain

Tags: Congress | FDA | GDUFA | Generic Drug Manufacturing | Press Releases

Posted October 30, 2019
Generic API Margins Being Squeezed?

Tags: API Manufacturing | CDMO | China | GDUFA | Generic Drug Manufacturing

Posted January 14, 2019
PCI Synthesis Identifies Trends Affecting the Generic Drugs Sector in 2019

Tags: API Manufacturing | CDMO | cGMP | FDA | GDUFA | Press Releases

Posted December 11, 2018
Why Drug Master Files Are An Important Part of API Manufacturing

Tags: API Manufacturing | Blog | DMFs | GDUFA

Posted September 21, 2018
Despite all the Rhetoric, Time-Consuming FDA Guidelines Make More Work for CMOs but Safe Products for Consumers

Tags: Blog | FDA | GDUFA | How to select a CMO | ICH | Pharmaceutical Manufacturing | Safety

Posted June 15, 2017
In Pharmaceutical Outsourcing: PCI Synthesis’ top trends for 2016. Did they pan out?

Tags: Articles | GDUFA | Pharmaceutical Outsourcing

Posted February 15, 2016
PCI Synthesis Predicts Key Trends Affecting The Generic Drugs Sector in 2016

Tags: GDUFA | Press Releases

Posted December 14, 2015
Grading GDUFA

Tags: Articles | Contract Pharam | GDUFA

Posted November 15, 2015