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
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Expedited reviews of drug submissions
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Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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