ePT--the Electronic Newsletter of Pharmaceutical Technology, Mar 22, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Mar 22, 2012
News
FDA Updates Sentinel Initiative Status
By Susan Haigney
In a presentation published on FDA's website on Mar. 15, 2012, Janet Woodcock, director of CDER, outlined the current status and future plans for FDA's Sentinel Initiative, an electronic drug safety tracking system established as part of the FDA Amendments Act of 2007.
FDA Warns Teva Pharmaceuticals About Improper Promotional Materials
By Amy Ritter
Teva Pharmaceuticals received a Warning Letter from FDA informing them that promotional materials as well as an associated webpage for Copaxone (glatiramer acetate injection) solution for subcutaneous injection were found to be false and misleading.
EMA Says Ben Venue's Anticancer Drugs Should be Manufactured in Another Facility
By Stephanie Sutton
The European Medicines Agency has recommended that manufacturing processes for two anticancer medicines be transferred from Ben Venue Laboratories to alternative facilities. The decision follows GMP shortcomings identified at the US-based manufacturer in late 2011, and marks the end of the EMA's review of all fourteen centrally authorized medicines that were produced at the site.
UK Union to Fight Closure of Sanofi UK Manufacturing Facility
By Patricia Van Arnum
Unite, Britain and Ireland's largest trade union with 1.5 million members, said it will fight the closure of Sanofi's pharmaceutical manufacturing facility in Newcastle-upon-Tyne in northeast England. Last week, Sanofi announced the closure of the facility, which employs 450 people and makes solid-dose oral drugs mainly for the UK and European markets.
Week of Mar. 19, 2012: FDA Issues Warning Letter to Warner Chilcott; Sigma-Aldrich Expands in Asia; and More
FDA Issues Warning Letter to Warner Chilcott; Sigma-Aldrich Expands in Asia; and More.

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