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FDA Issues Draft Guidance on Biosimilar Product Development

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(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration (FDA) has issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

Health Care Lean, Six Sigma, and Process Excellence Conferences

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(WCBF: Chicago) -- The Worldwide Conventions and Business Forums (WCBF), an independent organization headquartered in Chicago that researches and produces high-quality, senior-level lean, Six Sigma, and process excellence events, has a predominant mission for 2012.

Three-Day ISO 13485 Internal Auditor Training

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(University at Buffalo: Buffalo, NY) -- The ISO 13485 internal auditor training program from the University at Buffalo provides the skills necessary to perform process audits in the medical device industry, which results in findings for continual improvement.

FDA and Industry Reach Agreement in Principle on Medical Device User Fees

  • Read more about FDA and Industry Reach Agreement in Principle on Medical Device User Fees
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(FDA: Silver Spring, MD) -- The Food and Drug Administration (FDA) and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program.

International Summit on Improving Patient Care in the Office Practice and Community

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(IHI: Cambridge, MA) -- The Institute for Healthcare Improvement (IHI) has announced details of its 13th Annual International Summit on Improving Patient Care in the Office Practice & the Community.

Health Care Costs, Deaths Reduced in National Initiative’s First Three Years

  • Read more about Health Care Costs, Deaths Reduced in National Initiative’s First Three Years
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In three years, 157 hospitals participating in the Premier health care alliance’s QUEST have saved an estimated 24,820 lives and reduced health care spending by nearly $4.5 billion.

ISPE Supports Pharmaceutical Industry with Guide for Project Management

  • Read more about ISPE Supports Pharmaceutical Industry with Guide for Project Management
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(ISPE: Tampa, FL) – The International Society for Pharmaceutical Engineering (ISPE) has released a new industry guidance document, Project Management for the Pharmaceutical Indus

Thomson Reuters Announces Top U.S. Health Systems

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(Thomson Reuters: Ann Arbor, MI) -- Thomson Reuters has released its fourth annual study identifying the top U.S. health systems based on balanced, systemwide clinical performance.

NSF International Expands Medical Device and Pharmaceutical Services

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(NSF: Ann Arbor, MI) -- NSF-DBA, an NSF International Health Sciences company providing training, consulting, and auditing for the pharmaceutical and biopharmaceutical industries, has acquired UK-based medical-device training and consulting company, Pink Associates, with the company’s managing di

Thomson Reuters Forecasts Onset of the Targeted Drug Discovery Era

  • Read more about Thomson Reuters Forecasts Onset of the Targeted Drug Discovery Era
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(Thomson Reuters: New York) -- In recognition of the International Year of Chemistry 2011, Thomson Reuters published a research report analyzing The Changing Role of Chemistry in Drug Discovery.

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