FDA: Innovation Spoken Here
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These days, even regulatory agencies must innovate if they expect to keep pace with the speed of doing business. The U.S.
Canada's MDSAP Mandate Could Be Bad for Canadian Healthcare
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The Dec. 31, 2018 deadline looms for medical device companies that sell their devices in Canada.
Quality’s Role in Biomedical Morals and Ethics
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The future is the ultimate abstraction; anyone who has ever attempted to discern the nature of tomorrow by looking at the yesterdays leading up to today knows that prediction is a fool’s errand.
Life Science Pioneer Takes Cues From 21 CFR and ISO 13485
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One of the unique aspects of Finch Therapeutics is that although its product does not fall easily into any regulated category and thus is not FDA-approved, the company has been working closely with the agency for at least five years.
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
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
‘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
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
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.
