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Pharmaceutical Technology Europe
Volume 23, Issue 11

News bites

EMA invites feedback
The EMA released two concept papers for a 3month public consultation that address the need to revise existing guidelines on biosimilar medicines and influenza vaccines. Feedback can be submitted until 31 December 2011.

Read more at: http://www.pharmtech.com/EMApapers

AstraZeneca in China
AstraZeneca is investing $200 million in a new manufacturing facility in China for intravenous and solid medicines. The facility will be located in Taizhou, with construction due to finish at the end of 2013, and will help the company to expand its medicines availability in urban and rural communities.

Read more at: http://www.pharmtech.com/azinchina

GSK and fast cars
GSK has formed a long-term partnership with the UK-based McLaren Group, which is best known for its expertise in the Formula 1 motor sport. McLaren will share its capabilities in engineering, technology, analytics and strategy modelling to help improve GSK's manufacturing, R&D and consumer-healthcare areas.

Read more at: http://www.pharmtech.com/formula1

FDA enhances database
The FDA is considering whether to enhance its inspections database by adding specific search criteria that would both enhance data analysis and make the system more user friendly. The idea was included in a list of eight draft proposals for increasing transparency that the agency published in October.

Read more at: http://www.pharmtech.com/fdasearch

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
33%
Breakthrough designations
17%
Protecting the supply chain
50%
Expedited reviews of drug submissions
0%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Source: Pharmaceutical Technology Europe,
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