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Regulatory & Safety: Top Headlines

Diluent mix-up not vaccine most probable cause of Syrian deaths says WHO

Picture credit/Measles Control Taskforce Facebook page

18-Sep-2014 - Use of the muscle relaxant atracuriam to resuspend freeze-dried measles vaccines instead of the proper diluent almost certainly caused the death of more than a dozen Syrian infants according to the WHO.

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Dispatches from ChemOutsourcing

ICH elemental impurities guideline expected to be finalized at end of September

18-Sep-2014 - After much discussion and some confusion , the ICH’s (International Conference on Harmonization) Q3D guideline , which will govern elemental impurities in final drug products, is expected to be finalized at the end of this month.

US FDA warns patients off all products from Texas compounding pharmacy

17-Sep-2014 - The US FDA has warned the public not to use any sterile medicines made by Downing-owned NuVision Pharmacy, Texas, which failed to comply with a recall order.

update

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

17-Sep-2014 - Shifting EMA oversight to DG Enterprise and Industry will put patients at greater risk of adverse events according to NGO Health Action International, which suspects EFPIA “had a hand” in European Commission reshuffle plan.

Trial transparency: NICE stands firm on data

16-Sep-2014 - The UK’s NICE says it will go over drug companies’ heads and get clinical trial data from regulators if sponsors fail to supply their results.

EMA guideline on pharmacovigilance inspections comes into effect

16-Sep-2014 - As the EMA has announced that the main objectives of its pharmacovigilance legislation are largely being achieved , the agency is still implementing a number of the individual modules that make up the over-arching law.

EC rejig will see DG Enterprise and Industry take responsibility for EMA

15-Sep-2014 - The EU commission plans to strip DG Sanco of responsibility for the running the EMA and hand it to the directorate in charge of enterprise and industry.

News in brief

Human hair in heparin vial prompts Hospira recall

15-Sep-2014 - Hospira has pulled a lot of heparin sodium after human hair discovered in vial.

Regulatory & Safety: Featured news

Spotlight

Ben venue fallout continues to cause headache for Boehringer Ingelheim

Ben venue fallout continues to cause headache for Boehringer Ingelheim

Divested sterile manufacturer Ben Venue has continued to cause trouble for Boehringer Ingelheim with a second recall...

‘James bond’-like tech is the end to overdoses, says formulation firm

‘James bond’-like tech is the end to overdoses, says formulation firm

Canadian drugmaker Intellipharmaceutics has developed a kill-switch formulation it says will prevent drug misuse and accidental overdoses.

Find other oral forms for tablet-hating patients, drugmakers told

Find other oral forms for tablet-hating patients, drugmakers told

Pharma firms must provide imaginative solid dosage alternatives to tablets and capsules, says research claiming more than...

Gangsters imported fake drugs from Asia says Europol

Gangsters imported fake drugs from Asia says Europol

Millions of fake pharmaceuticals seized earlier today were imported from Asia by an organised crime group that...

Compounding the problem: US warns two more pharmacies

Compounding the problem: US warns two more pharmacies

The US FDA has criticised the Compounding Shop and Zion Rx Formulations Services for making unapproved and...

Is Pfizer now eyeing up Actavis three months after failed AZ bid?
INFOGRAPHIC

Is Pfizer now eyeing up Actavis three months after failed AZ bid?

Pfizer is rumoured to be eyeing up Actavis three months after failing to woo AstraZeneca in a...

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