NDA

Showing 8 posts of 23 posts found.

Proteus system

US FDA accepts first digital medicine application

September 11, 2015
Medical Communications FDA, NDA, Otsuka, digital, digital medicine, proteus

The FDA has accepted the first New Drug Application for a digital medicine: Otsuka and Proteus Digital Health’s collaboration of …

BMS image

BMS resubmits hepatitis C drug

March 13, 2015
Sales and Marketing BMS, NDA, daclatasvir gilead, hepatitis C, sovaldi

Bristol-Myers Squibb has resubmitted its hepatitis C (HCV) treatment for FDA approval despite previously backing out, as it spots a …

FDA image

FDA approvals: 1996 versus 2014

January 12, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, John LaMattina, LaMattina, NDA, US, appovals, drugs

As highlighted in a number of recent stories, 2014 was a banner year for the biopharmaceutical industry with 41 new …

GSK image

GSK submits melanoma drugs for regulatory approval

August 3, 2012
Sales and Marketing FDA, GSK, NDA, Zelboraf, melanoma, oncology

GlaxoSmithKline has submitted its two investigational melanoma drugs to regulators in both Europe and the US. The firm is seeking …

Ex-EMA chief ran consultancy firm whilst still in office

December 19, 2011
Sales and Marketing EMA, Lonngren, NDA

The former head of the European Medicines Agency Thomas Lonngren set up his own consultancy business to advise pharma whilst …

Graham Higson joins NDA Group to lead Regulatory and HTA Advisory Board

November 4, 2011
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing NDA

GE Healthcare and ex AstraZeneca Head of Global Regulatory Affairs, Graham Higson, will join NDA Group in January 2012 to …

European medicines legislation and pharmacovigilance

October 20, 2010
Research and Development NDA, pharmacovigilance, regulatory affairs

During the past decade, changes in European medicines legislation and guidelines have increased the scope and regulatory scrutiny of pharmacovigilance …

NDA_Panos

NDA appoints Dr Panos Tsintis

June 22, 2010
Sales and Marketing NDA, appointment, sales and marketing

European regulatory affairs consulting group NDA has appointed Dr Panos Tsintis medical advisor to NDA Regulatory Science in a move …

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