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  Pharmaceutical Technology Europe E-Alert
 
JULY 17, 2009
IN THIS ISSUE
UK chemical threat
$3 billion boost for FDA
FDA anticounterfeiting guide
EU Pharmacopoeia strategies
More...

UK chemical industry under threat
In the wake of Dow Chemical’s announcement that it is to close facilities in the UK, the country’s biggest union, Unite, has called for urgent intervention from the Government to avert, what it believes, could be a crisis in the UK chemical sector. More...

Approximately $3 billion boost for FDA
Last week, the US House of Representatives passed H.R. 2997, the Fiscal Year 2010 Agriculture-FDA Appropriations bill, which sets aside $2.995 billion for the US Food and Drug Administration. More...

New FDA anticounterfeiting draft guidance
The FDA issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on 13 July. More...

European Pharmacopoeia Commission announces new strategies
The European Pharmacopoeia Commission, which will celebrate its 60th anniversary this year, has announced progress towards international harmonization, as well as other ongoing activities, at the 134th session of the European Pharmacopoeia in France .More...

Final counterfeit gang member sentenced
The UK’s largest counterfeit drug operation has ended in the sentencing of its seventh and final member. More...

All aboard the Twitter bandwagon
Resistance to the social networking revolution has been particularly high amongst pharmaceutical industry professionals, though now it seems that more and more are coming round to the idea. Interestingly, it’s not only the pharma elite that are jumping on the bandwagon; so too are government agencies and, most notably, the FDA. More...

US Committee votes on generic competition
This week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) issued their opposing statements in reaction to the 13 July passage of an amendment from the US Senate Committee on Health, Education, Labor, and Pensions (HELP) regarding the creation of a pathway for the approval of new competitors of biologic drugs. More...

MHRA offers online reporting for antiviral meds
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) intends to keep a close eye on the safety of the swine flu antiviral medicines Tamiflu and Relenza as their use increases, by using an online reporting system. More...

SOCMA supports extension of CFATS
The Society of Chemical Manufacturers and Affiliates (SOCMA) this week stated its support to the US Senate for approving legislation that would extend existing chemical security standards for one more year. More...

Pharma gets stuck into tropical diseases
Less well-known tropical diseases are receiving growing attention and research efforts from the pharmaceutical industry, according to a report from the Federation of Pharmaceutical Manufacturers & Associations (IFPMA). More...

IMA Group acquires PharmaSiena
Through its subsidiary IMA Life Srl, IMA SpA has acquired 51% of PharmaSiena Srl, which designs and produces filling machines for ampoules and syringes in aseptic environments. More...

 

Key Topic Updates
August events
11th Annual Drug Discovery Technology & Development World Congress (MA, USA)
Pharmaceutical User Forum (UK)
7th World Congress on alternatives and animal use in the life sciences (Italy)
Submit your event
 
Latest articles
Nanotechnology: the next silver bullet?
Dynamic avalanching accurately assesses flowability and quality
Human error costs industry billions
More latest articles
 
Validation articles
Why we need mass serialization — now!
EU and US unite against rare diseases
Managing the risks of PAT
More validation articles

Key Topic Updates

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  Poor pipeline 37%
  Stringent regulations 11%
  Counterfeits 30%
  Generic competition 9%

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