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Regulatory & Safety: Top Headlines

Drugs stolen while trucker changed his clothes recovered thanks to hidden GPS

FreightWatch: GPS a must for trucks carrying pharma cargo

03-Aug-2015 - A shipment of drugs stolen while a truck driver went home to change his clothes were recovered in half an hour thanks to a GPS tracking device embedded in the cargo.

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News in brief

FDA offers draft guidance on quality metrics used to assess drug manufacturing

29-Jul-2015 - New FDA draft guidance offers drug and API manufacturers a peek into the measurements or metrics that will be used to evaluate the quality of the facilities and the processes that they use to make drugs and biologics.

PEOPLE ON THE MOVE

Senior changes at Sanofi-Merck JV, Novo Nordisk, ABPI, and MedImmune

28-Jul-2015 - New faces in pharma in our weekly column.

Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan

28-Jul-2015 - The Senate Committee on Appropriations has approved $2.6bn in funding to the US FDA for FY2016.

EU and Swiss regulators strengthen ties with confidentiality agreement

27-Jul-2015 - A confidential information exchange agreement will strengthen the relationship between the EMA and Swiss regulators and could save on resources, the agencies say.

First part of European fake fighting database linked to securPharm

23-Jul-2015 - The first part of a Europe-wide database intended to help identify fake drugs is operational after being linked to Germany’s securPharm system.

Funds worth €3.5tr back Alltrials, but none promise to pull cash from drug firms that don't

23-Jul-2015 - Investor backing puts transparency on the pharma agenda says SenseAboutScience, even though none of the funds pledging support for Alltrials have committed to pull investment from drug firms that disagree.

Compound sentence? Two 'outsourcing facilities' hit with US FDA warning letters

22-Jul-2015 - Inspectors found significant violations of cGMP at sterile drug compounders - both registered as outsourcing facilities - in Florida and Arkansas during visits in March.

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