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News & Press: Regulatory Updates

PHSS Regulatory Update April 2015

14 April 2015   (0 Comments)
Posted by: Tamsin Marshall
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PHSS Regulatory Update April 2015

Europe

USA

 New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015
 Development and Submission of Near Infrared Analytical Procedures 
 FDA approves first biosimilar product
 Public docket on drug compounding
 Final guidance on reprocessing of reusable medical devices
 Electronic Submission of Lot Distribution Reports; Guidance for Industry (Biologics)

International

Canada

  • Inspection Tracker: Drug Manufacturing Establishments

PIC/s

  • Thailand applies for membership  

Products

  • Treanda Injection (solution) and closed system transfer devices

 


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