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15 Feb 2018

China De-Risking, New Regulations — The Pharma Outsourcing Challenges of 2018

Last year, we had interviewed Parul Oza, Managing Director of CRMO Pharmatech, to better understand ICH Q11, and the US Food and Drug Administration’s adoption of the same.  The ICH Q11 are guidelines for the developmen...

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China De-Risking, New Regulations — The Pharma Outsourcing Challenges of 2018

15 Feb 2018

FDA seeks changes in 180-day exclusivity for generics; Data-integrity concerns at Bayer`s German facility

This week, Phispers brings you news on the FY 2019 budget proposals in the US that seek to change the way generic drugs come to market. Gilead’s big triplet for HIV — Biktarvy — won the FDA nod, even as GSK swift...

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FDA seeks changes in 180-day exclusivity for generics; Data-integrity concerns at Bayer`s German facility

08 Feb 2018

India’s antibiotic crisis: Pollution, Unapproved Drugs, Overdosed Poultry

In June 2015, PharmaCompass reported on antibiotic contamination in rivers in China, which wasn’t a result of the factories that produce antibiotics. The issue had opened another battlefront for the global war on superb...

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India’s antibiotic crisis: Pollution, Unapproved Drugs, Overdosed Poultry

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