ePT--the Electronic Newsletter of Pharmaceutical Technology, Aug 11, 2011 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Aug 11, 2011
News
FDA, EMA Say Future Joint API Inspections Likely
By Rich Whitworth
EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. FDA has also reached a similar conclusion based on the findings.
Pfizer's $50-Million Drug-Discovery Partnership
By Stephanie Sutton
Pfizer has partnered with the University of California's San Diego Health Sciences in a drug discovery collaboration that could see Pfizer invest up to $50 million over the next five years in the development of new therapies.
For Biosimilars, No “One Size Fits All”
By Amy Ritter
Since the passage of the BPCI Act in 2009, manufacturers have been waiting for guidance from FDA on what that approval process will look like.
SOCMA Comments on EPA's Chemical Data Reporting Rule
By Patricia Van Arnum
The Society for Chemical Manufacturers & Affiliates commented on EPA's modifications to the Inventory Update Reporting rule, also broadly know as the Chemical Data Reporting rule. EPA issued the final rule earlier this month.
Week of August 8, 2011: Catalent Expands Global Cold-Chain Supply Operations; Nycomed US Names Brian A. Markison as CEO; and More.
Catalent Expands Global Cold-Chain Supply Operations; Nycomed US Names Brian A. Markison as CEO; and More.
Regulatory Roundup: FDA Issues Final Guidance Regarding cGMPs for PET Drugs
FDA Issues Final Guidance Regarding cGMPs for PET Drugs.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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