ePT--the Electronic Newsletter of Pharmaceutical Technology, Jan 5, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jan 5, 2012
News
FDA Draft Guidance Offers Social Media Insight
By Stephanie Sutton
The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.
Ben Venue Continues Suspension of Manufacturing Activity at Ohio Facility
By Patricia Van Arnum
Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.
NIH Establishes National Center for Advancing Translational Sciences
By Amy Ritter
The National Institutes of Health has established the National Center for Advancing Translational Sciences, a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices.
FDA Creates Shared REMS System for TIRF Medicines
By Susan Haigney
On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.
Week of Jan. 2, 2012: AMRI Restructures; ISPE Appoints Nancy S. Berg as CEO; and More
AMRI Restructures; ISPE Appoints Nancy S. Berg as CEO; and More.
Regulatory Roundup: USP Releases Proposed Supply Chain Guidelines
USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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