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FDA Requests $4.03 Billion for FY2011-a 23% Increase
The US Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President's fiscal year 2011 budgeta 23% increase over the agency's current $3.28 billion budget.The FY 2011 request, which covers the period...
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AstraZeneca Drops the Axe Again and Cuts 8,000 Jobs
_ AstraZeneca Drops the Axe Again and Cuts 8,000 Jobs.
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Regulatory Relief: An Idea Whose Time Has Come
Laura Bush In October 2005, the US Food and Drug Administration and AAPS co-sponsored a workshop on pharmaceutical quality assessments.The theme of the conference was to establish a path for drug manufacturers to demonstrate sufficient process understanding...
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Supplier Quality Management: A Risk-Based Approach
Bob Rhoades Melamine-tainted baby formula and pet food.Allergic reactions and deaths from contaminated heparin. Recent events have made supplier quality issues a top priority, for both the biopharmaceutical industry and its regulators in the US and Europe....
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Quality by Design and Compliance Readiness
Biopharmaceutical companies undertaking Quality by Design (QbD) initiatives find themselves in the quandary that accompanies any significant advance in life sciences manufacturing: If we implement a far-reaching change in the way we operate, what will it mean...
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QbD: A Roadmap to Adoption
Todd Hein The life sciences industry is experiencing a significant transformation caused by market pressures.In response, leaders of pharmaceutical and biotech organizations of all sizes are looking to streamline the R&D process, provide greater...
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Issues and Opportunities Challenge Biotech Manufacturers
Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.BioPharm International 12 Jill Wechsler After a year of considerable turmoil in Washington policy and regulatory circles, there is optimism that...
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Extractables & Leachables Testing for Single-Use Bioprocessing Equipment Assessing Risk, Leveraging Knowledge, and Protecting Patients
_ Extractables & Leachables Testing for Single-Use Bioprocessing Equipment Assessing Risk, Leveraging Knowledge, and Protecting Patients.
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Addressing the Challenges of Downstream Processing, Today and Tomorrow
_ Addressing the Challenges of Downstream Processing, Today and Tomorrow.
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Biopharmaceutical Job Market: 2010 and Beyond
_ Biopharmaceutical Job Market: 2010 and Beyond.
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