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Top Five Things Life Science Companies Need to Know about ISO and FDA Requirements

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Life science companies play a major role in the global economy, with revenues expected to reach a staggering $1.5 trillion by 2020.1 Such a rosy forecast is likely to attract innovators and encourage current industry players to blaze new trails.

Occupational Health and Safety: A Standard Approach

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An international standard that specifies requirements for an occupational health and safety (OH&S) management system, ISO 45001:2018—“Occupational health and safety management systems–requirements” replaces OHSAS 18001 as the primary OH&S standard used intern

FDA Advances Efficient Approaches to Designing and Conducting Cancer Clinical Trials

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During the past decade, advances in understanding of cancer biology have led to the development of targeted treatments that are more effective than the chemotherapies of the past century.

Inside Quality Digest Live for August 10, 2018

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‘Culture” is one of those business-speak words that’s used a lot, but for a good reason—having the right one is the key to unlocking your company’s quality potential. On the other hand, nothing will overcome a poor culture. Do you know which you have?

The American Chamber of Horrors

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During the early 20th century, Americans were inundated with ineffective and dangerous drugs, as well as adulterated and deceptively packaged foods.

Three Things Medical Marijuana Startups Need to Thrive Despite Regulatory Uncertainty

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The medical marijuana industry is being heralded as the new frontier in the life sciences, thanks to the potential of cannabis-derived products in treating ailments that range from chemotherapy-induced nausea to epilepsy and neuropathic pain.

FDA Proposes Process Modernization to Support New Drug Development

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The staff of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) always tries to utilize cutting-edge science and up-to-date process management, befitting our stature as the global “gold standard” in drug regulation.

Benefits of FDA’s Breakthrough Device Program

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How to Leverage an EQMS for Managing Product Adulteration

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New Steps to Facilitate Medical Device Innovation

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In recent days, the U.S. Food and Drug Administration (FDA) has committed to several new policies that will modernize the agency’s approach to regulation in the medical device system.

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