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3 October 2011

IN THIS ISSUE
• Unapproved drugs
• EMA opinions
• Water contamination
• FDA guidance



FDA publishes guidance on marketed unapproved drugs The FDA has published a guidance on Marketed Unapproved Drugs—Compliance Policy Guide, which describes the agency’s enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review. More...

EMA offers positive opinion on new drugs The latest meeting of the EMA’s Committee for Medicinal Products for Human Use has concluded with more than 15 positive opinions for new and generic drugs and the adoption of key concept papers. More...

Concern over pharma-contaminated water The public has been concerned about pharmaceuticals in the water supply for some time and new research from French scientists may add to the alarm after diuretics and anti-inflammatory agents were identified in a river. More...

New FDA guidance on user fee waivers, reductions and refunds The FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines the agency’s policies for issuing waivers, refunds or reductions in prescription drug user fees. More...

Join our community on LinkedIn Want to discuss any of this week's news stories or any other hot topics in the industry? Then why not join our group on LinkedIn? More...

Latest columns

Building toolboxes in pursuit of single enantiomer drugs

The EU debt crisis and CMOs

Reducing the risk in risk management

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PTE Digital

The predicted growth of the API market

The fine chemicals market

Highly potent; highly challenging?

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Upcoming events

BioProduction 2011 (19–20 October | Germany)

INTERPHEX Puerto Rico (20–21 October | Puerto Rico)

AAPS (23–27 October | USA)

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Product/Service Profiles

Oxoid

Genetic Identification and Characterization in less than 8 Hours
The DuPont Qualicon RiboPrinter^® microbial characterization system provides the speed, accuracy and resolution needed to identify bacteria and compare them at the strain level characterization, all in less than 8 hours. This automated system is available in Europe, Canada and Australia alongside Oxoid products. Read more

Intertek

Reviewing your 2012 analysis outsourcing plans?
Whether your needs cover GLP/ GCP Bioanalysis, GMP Biopharma and Pharma analysis, GMP Auditing, Method development and Validation or GMP Microbiology book a meeting with the Intertek Team (41D57) at ICSE / CPhi.
Read more

Wockhardt

From development to high-volume commercial manufacture, Wockhardt utilizes more than 25 years of contract manufacturing experience to ensure your product is professionally managed all the way to market. Read more

Event Profile

QP Association
Get an update on all developments relevant to European QPs and benefit from the opportunity to network with regulators and industry experts – at the 6th QP Forum in Budapest, Hungary, from 1-2 December. Read more

BioManufacturing World China 2011
Nov 30 –Dec 1 2011
Shanghai, China
BioManufacturing World China, co-located under Bio World China 2011 aims to bring together international and China biopharmaceutical manufacturing leaders, technical and operational heads and technology providers and other stakeholders to come together to establish and renew partnerships to help develop new products, acquire new process technologies, and establish new contract manufacturing relationships. Read more

FDA released its new enforcement strategy in August 2010. Has your company experienced FDA increased scrutiny in the past year?

■	Yes	58%

■	No	42%

This week we would like to know...

Who should drive universal anticounterfeiting solutions?

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