Latest News in the pharma Industry

Policy & Regulation

EU-GMP: New Annex 16 Released

EU-GMP: New Annex 16 Released

11 Jul 2013

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EC approves new dosing of HCV drug

EC approves new dosing of HCV drug

12 Jun 2013

Patients will be able to take the drug twice rather than three times daily.

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Stivarga Approved for Use in Europe

Stivarga Approved for Use in Europe

9 Jun 2013

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Rx-360 Summary of EU’s Falsified Medicines Directive rule (Article 46b 2011/62/EU)

Rx-360 Summary of EU’s Falsified Medicines Directive rule (Article 46b 2011/62/EU)

8 Jun 2013

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Rx-360 Summary of Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

Rx-360 Summary of Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products

8 May 2013

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Novartis Drug Lucentis Approved in EU as First Effective Anti-VEGF Treatment for Myopic Choroidal Neovascularization

Novartis Drug Lucentis Approved in EU as First Effective Anti-VEGF Treatment for Myopic Choroidal Neovascularization

7 May 2013

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New FDA Regulation Gives the Agency More Power During an Inspection

New FDA Regulation Gives the Agency More Power During an Inspection

9 Apr 2013

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RAPS Releases New Edition of Essential US Regulatory Affairs Reference Book

RAPS Releases New Edition of Essential US Regulatory Affairs Reference Book

7 Apr 2013

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Breast Cancer Drug Approved for Use in Wales

Breast Cancer Drug Approved for Use in Wales

9 Mar 2013

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Sunshine Act to cast a light on physician interactions with drug makers

Sunshine Act to cast a light on physician interactions with drug makers

26 Feb 2013

The National Physician Payment Transparency Program aims to pull back the curtain on physician-pharmaceuticals relations.

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US FDA norms on Clinical Pharmacogenomics may provide clear rules for new drug devpt

US FDA norms on Clinical Pharmacogenomics may provide clear rules for new drug devpt

16 Feb 2013

The US Food and Drug Administration (FDA) has now issued the guidance for Industry on Clinical Pharmacogenomics which refers to a Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for labelling.

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Govt forms panels to frame guidelines & SOPs for approval of new drugs, trials, banning drugs

Govt forms panels to frame guidelines & SOPs for approval of new drugs, trials, banning drugs

16 Feb 2013

The Union health ministry has constituted two expert committees to formulate policy guidelines and standard operating procedures (SOPs) for approval of new drugs, clinical trials, banning of drugs and Fixed Dose Combinations (FDCs).

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