Latest News in the pharma Industry

Policy & Regulation

China Finally Allows FDA To Add Inspectors

China Finally Allows FDA To Add Inspectors

9 Dec 2013

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Risk Assessment for Ascertaining GMP for Excipients

Risk Assessment for Ascertaining GMP for Excipients

5 Dec 2013

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Rx-360 Applauds Passage of Drug Quality and Security Act

Rx-360 Applauds Passage of Drug Quality and Security Act

29 Nov 2013

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FDA Warning Letter Statistics 2013 Regarding Process Validation/Qualification/Calibration

FDA Warning Letter Statistics 2013 Regarding Process Validation/Qualification/Calibration

28 Nov 2013

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FDA Approves Merck’s NOXAFIL (posaconazole) Delayed-Release Tablets

FDA Approves Merck’s NOXAFIL (posaconazole) Delayed-Release Tablets

27 Nov 2013

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Xigduo (Dapagliflozin and Metformin Hydrochloride) Receives Positive CHMP Opinion in the EU for the Treatment of Type 2 Diabetes

Xigduo (Dapagliflozin and Metformin Hydrochloride) Receives Positive CHMP Opinion in the EU for the Treatment of Type 2 Diabetes

27 Nov 2013

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FDA Approves NEXAVAR (Sorafenib)

FDA Approves NEXAVAR (Sorafenib)

25 Nov 2013

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CHMP Determines Dimethyl Fumarate in TECFIDERA to be a New Active Substance in the EU

CHMP Determines Dimethyl Fumarate in TECFIDERA to be a New Active Substance in the EU

25 Nov 2013

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FDA Grants Regular Approval for Crizotinib

FDA Grants Regular Approval for Crizotinib

22 Nov 2013

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Revision of the EU GMP Guide: EU Commission Publishes Comments for Chapters 3, 5, 6 and 8

Revision of the EU GMP Guide: EU Commission Publishes Comments for Chapters 3, 5, 6 and 8

21 Nov 2013

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FDA Should Take Action on ‘Unfeasible Guidances’ to Help Boost Stagnant US Antibiotics Market

FDA Should Take Action on ‘Unfeasible Guidances’ to Help Boost Stagnant US Antibiotics Market

20 Nov 2013

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European Medicines Agency Updates on Development of its Policy on Publication and Access to Clinical Trial Data

European Medicines Agency Updates on Development of its Policy on Publication and Access to Clinical Trial Data

13 Nov 2013

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