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MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

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European regulators begin rolling review of AZ’s COVID-19 vaccine

pharmaphorum

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford. The post European regulators begin rolling review of AZ’s COVID-19 vaccine appeared first on.

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Opinion: The FDA is the right agency to regulate CBD products, but it needs help

STAT News

The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. But the FDA turned down industry trade groups , and for good reason.

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Thousands of toddler sippy cups and bottles are recalled over lead poisoning risk

NPR Health - Shots

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. No injuries have been reported from such incidents. Image credit: U.S. Consumer Product Safety Commission)

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After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

Fierce Pharma

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns. Following a controversy over Covis’ preterm birth drug Makena in the U.S.

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Transforming cold chain infrastructure: ‘Ultra-cold smart container can transport all of the leading vaccine candidates for COVID-19’

BioPharma Reporter

Up to 10% of vaccines can be reportedly lost in transit due to breakage or fluctuations in sub-zero temperatures required for preservation, but a manufacturer of data-driven temperature-controlled smart containers says it can cut that rate to just 0.1%.

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Is the FDA Doing Enough to Regulate Added Chemicals in Foods?

XTalks

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. Some of these chemicals are known endocrine (hormone) disruptors linked to developmental, cognitive and other health problems in babies and adults.