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News & Press: Regulatory Updates

PHSS Regulatory Update September 2015; MHRA advises clinical grade; Botanical drug development

08 September 2015   (0 Comments)
Posted by: Tamsin Marshall
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Introduction


During the last 4 weeks there have been a number of developments in the regulation of the pharmaceutical industry. This month reported issues have come from the EU and USA regulatory authorities.

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

 

Europe

  • TxCell manufacturing facility in Besançon shut down following Inspection by Frances ANSM
  • Medical Devices - proposal for a regulation of the European Parliament and of the Council
  • MHRA advises on emerging clinical grade induced pluripotent stem cells bank regulation.

USA

  • Botanical drug development
  • Entities considering whether to register as outsourcing facilities
  • Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices
  • FDA warns about prescribing and dispensing errors resulting from brand name confusion

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