Dec. 7, 2007 | Vol. 1 No. 24
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched a dedicated 24-hour hotline for reporting counterfeit drugs as part of its 2007–2010 strategy for combating fake pharmaceuticals.
Discovery Labs expects FDA action on its respiratory distress syndrome treatment Surfaxin during the first half of 2008 following its response to a second FDA approvable letter.
A recent FDA warning letter to Arrow International for its quality system violations is the company’s final warning prior to regulatory action.
Pharmaceuticals-maker Bristol-Myers Squibb said that it would lay off about 4,300 employees and close more than half of its manufacturing plants as part of a broad restructuring aimed at saving $1.5 billion by 2010.
Five years from now, Eli Lilly could look like a different company, with fewer employees and plants, as it shifts more of its scientific research, manufacturing, sales and administrative work from Indianapolis to outsiders around the world.
The western drug industry is also joining the outsourcing queue.
Medical device maker Abbott Laboratories says it is cutting 1,200 manufacturing jobs from facilities in Ireland and California.
China’s campaign to make its drugs safer is showing results, its food and drug administration said Monday, with over 7,300 pharmaceutical companies withdrawing applications for drug approval under new rules.
A proposed FDA rule to make electronic medical device reporting (eMDR) mandatory is scheduled for release in February.
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