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FDA Tries a New Approach With Guidance On Opioid Use Disorder Medications

​ In the U.S., the opioid epidemic is recognized as a growing public health crisis that has been identified across all levels of socioeconomic status. Within the last 16 years, it is reported that more than 183,000 Americans...

source: 05/24/18, Dr. Abimbola Farinde
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The Food and Drug Administration recently sent warning letters based on facility inspections noting violations of current good manufacturing practices.


Scientists working with fetal tissue will automatically have their grant applications pulled from consideration if they do not justify why they need to use it, the National Institutes of Health said.


Medical research funding is all but guaranteed an increase in 2020, after the White House and Congress reached an agreement on a budget, a research advocate says.


Scientists whose basic human research now counts as a clinical trial are getting two more years before they have to follow reporting and registration requirements that already apply to drug and device company studies.


Combination therapy of two or more molecules with complimentary pharmacological effects has led to an increased interest in development of coformulation products. This article discusses the challenges and strategies for coformulation development of biologics. Read the full...


Thanks to blockchain technologies, supply chain teams can now track the safety and traceability of products and data across the entire supply chain in ways — and at speeds — once unimaginable. That is the impetus behind a new...

source: 07/29/2019, Compliance Week


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