ePT--the Electronic Newsletter of Pharmaceutical Technology, Jul 12, 2012 - Pharmaceutical Technology

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ePT--the Electronic Newsletter of Pharmaceutical Technology, Jul 12, 2012
News
Congress Passes Generic Drug Act
By Susan Haigney
On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.
FDA Introduces New Safety Measures for Opioid Medications
By Amy Ritter
On July 9, 2012, FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.
ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities
By Jennifer Markarian
ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.
Week of July 9, 2012: Amgen Completes Acquisition of KAI Pharmaceuticals; Renaissance Acquisition Holdings Acquires DPT Laboratories; and More
Amgen Completes Acquisition of KAI Pharmaceuticals; Renaissance Acquisition Holdings Acquires DPT Laboratories; and More.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
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Reducing drug shortages
32%
Breakthrough designations
11%
Protecting the supply chain
37%
Expedited reviews of drug submissions
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More stakeholder involvement
11%
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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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