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Regulatory & Safety: Top Headlines

Canadian manufacturer hit with warning letter over cross-contamination issues

06-Jul-2015 - Toronto-based Attix Pharmaceuticals has received a US FDA warning letter after an inspection from November and a lack of corrective actions in the company’s response to the FDA.

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News in brief

News in brief

Suspect Viagra pills seized in EU-wide swoop on organised crime gang

02-Jul-2015 - More evidence linking fake pharmaceuticals and organised crime emerged today with Dutch police seizing suspicious Viagra pills along with cocaine, MDMA and burglary tools.

UK will label drugs with their cost to the state

02-Jul-2015 - The UK health minister has announced plans to label all British prescription medicines with their cost to the taxpayer.

Staff cuts and accelerated access: MHRA’s plan for 2016

02-Jul-2015 - MHRA, the UK pharma regulator, says its staff cuts over the next three years will not impact its work with pharma.

New logo will help patients tell legit EU web pharmacies from illegal sites says EC

01-Jul-2015 - Europeans who want to fund organised crime can now do so more easily by buying meds from web pharmacies that lack a new logo launched by the EC to stop the sale of fakes online.

US FDA extends track-and-trace deadline for pharmacies

01-Jul-2015 - The US FDA says has granted a four month amnesty to pharmacies which do not comply with new track-and-trace regulations that come into force today.

Sequenom case leaves pharma confused over patent law

30-Jun-2015 - US IP rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

ICH clarifies Q7 guidance on API GMP manufacturing

30-Jun-2015 - In response to a flood of requests over uncertainties regarding ICH Q7 guidance, the international consortium recently released a question and answer (Q&A) document intended help companies implement appropriate GMPs (good manufacturing practices) at all stages of the API supply chain.

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