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Regulatory & Safety: Top Headlines

News in brief

Pfizer confirms it is evaluating Korea operations amid job cut rumours

02-Sep-2015 - Pfizer has confirmed it is in discussion with labour unions in Korea as part of an evaluation of its business in the country.

Progress seen In addressing US drug shortages, but challenges remain

31-Aug-2015 - New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade, the US FDA told in-Pharmatechnologist.

Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales

31-Aug-2015 - The US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products.

FDA opts for four-letter suffix to distinguish biologics and biosimilars

28-Aug-2015 - The US FDA has published long-awaited guidelines on the non-proprietary naming of biological products, but biosimilar makers say adding a random four-letter suffix could needlessly complicate the prescribing system.

MHRA uncovers $1m illegal ED drug haul

27-Aug-2015 - A UK man has been sentenced to 16 months in prison for smuggling illegal erectile dysfunction drugs following an MHRA investigation.

Europe, US, Japan: The recall round-up

27-Aug-2015 - Product problems for Allergan and Danish Leo Pharma, plus the Japanese regulator reviews a Bristol-Myers Squibb mAb.

MHRA launches fees calculator

26-Aug-2015 - The UK regulator is launching a calculator to help pharma companies calculate the fees for drug applications.

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