While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
May 1, 2013
By:
Sean Milmo
While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
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EU authorities are stepping up their efforts to incorporate QbD principles.
Apr 1, 2013
By:
Sean Milmo
EU authorities are stepping up their efforts to incorporate QbD principles.
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Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.
Mar 1, 2013
By:
Sean Milmo
Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.
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The EU fine-tunes the Falsified Medicines Directive.
Jan 1, 2013
By:
Sean Milmo
The EU fine-tunes the Falsified Medicines Directive.
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The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.
Nov 1, 2012
By:
Sean Milmo
The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.
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The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.
Nov 1, 2012
By:
Sean Milmo
The government of Turkey is drawing up a program in coordination with the pharmaceutical industry to create ways to make the country a regional production center for pharmaceuticals serving Europe, Central Asia, and the Middle East.
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