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What's New at FDA  Members only

What's New at EMA Members only

What’s New at MHLW Members only

September 2009

15 Sep 2009 China's SFDA Deputy Commissioner Wu Zhen meets CEO of the Danish Medicines Agency
14 Sep 2009 Draft Guidance for Industry and FDA Staff - Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation
11 Sep 2009 MHLW Pharmaceuticals and Medical Devices Safety Information
09 Sep 2009 The Proceedings of the "ICH Japan Symposium 2009", Tokyo, Japan, 12 June, 2009
08 Sep 2009 Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection ...
07 Sep 2009 Corrected Questions and Answers - Common Technical Documents for the Registration of Pharmaceuticals for Human Use
03 Sep 2009 FDA Study Indicates Most Industry Postmarketing Studies Meet Timelines
01 Sep 2009 Revision of PIC/S GMP Guide
01 Sep 2009 Australia's TGA Updates Increased Transparency of the Prescription Medicine Regulatory Process
01 Sep 2009 FDA Issues Draft Guidance on Risk Evaluation & Mitigation Strategies
01 Sep 2009 news link
01 Sep 2009 Australia's TGA News - New TGA Structure, New Code of Good Manufacturing Practice, and More
01 Sep 2009 Generic substitution appears to have increased competition in the Finnish pharmaceutical market
01 Sep 2009 Australia's TGA Announces Proposed Standards and Code of GMP for Human Blood and Blood Components, Human Tissues and Human Cellular Therapies
01 Sep 2009 China's SFDA solicits opinions on revised Good Manufacturing Practice for Pharmaceutical Products (GMP) a second time
01 Sep 2009 SFDA issues medical device GMP detailed rules and inspection standards for sterile medical devices and implantable medical devices
01 Sep 2009 US FDA Expands Presence Outside U.S. with Opening of Mexico City Post
01 Sep 2009 The Therapeutic Products Directorate (TPD) of the Health Products and Food Branch (HPFB) of Health Canada announces the requirements for ...
01 Sep 2009 The European Medicines Agency marks its 15th anniversary with a short film
01 Sep 2009 New area of Britain's MHRA website for the pharmaceutical industry launched



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