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News & Press: Regulatory Updates

PHSS Regulatory Update Jan 2016: Guidelines on testing for bact endo; EMA / small cell lung cancer

05 January 2016   (0 Comments)
Posted by: Tamsin Marshall
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PHSS January Regulatory Update 2016 

 

On this months PHSS Regulatory Update reported issues have come from the EU and USA regulatory authorities.

The topics covered in this edition of the “Update” include:

Europe

  • Guidelines for using the test for bacterial endotoxins
  • Raw materials of biological origin for the production of cell-based and gene therapy medicinal products

USA

  • CDER 2016 Priorities
  • FDA warns of potential contamination of drug shipments from explosions in Tianjin City
  • Advancement of emerging technology applications to modernize the pharmaceutical manufacturing base
  • Head lice infestation: developing drugs for topical treatment
  • Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products 

Products

  • Pembrolizumab (MSD)
  • EMA fast-tracks new oral treatment for non-small cell lung cancer
  • FDA elimiates the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone- containing diabetes medicines

 


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