All FDA articles – Page 2
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OpinionHopes and fears for remdesivir
Available resources for testing coronavirus treatments need to be used wisely
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NewsSurvey of US government scientists reveals politicisation worries under Trump
Political appointees and business influence blamed for damaging agencies’ ability to make science-based decisions
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BusinessCan existing drugs slow Covid-19?
The fastest route to treatments may be to repurpose existing drugs – if they work
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BusinessFDA freezes foreign facility inspections amid coronavirus pandemic
US regulator will rely on border checks and shared data, but some approval processes may be delayed
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BusinessCoronavirus pandemic will disrupt international supply chains
Halted production and transport restrictions are straining industries that rely heavily on China for supplies
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BusinessCancer and rare diseases dominated 2019 drug approvals
More streamlined review processes and changing R&D priorities have contributed to sustained increase in new medicines
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NewsSunscreen chemicals absorbed into skin at rates that require further safety tests
US drug safety body finds six common sunscreen ingredients enter bloodstream rapidly
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BusinessUS bans most flavoured vaping cartridges
Cartridge-based e-cigarettes in flavours other than menthol or tobacco without regulatory approval will be removed from sale
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BusinessNitrosamine contamination withdrawals spread to new drugs
After ranitidine recalls, EU regulators instruct companies to review all their products for potential impurities
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OpinionUnder a cloud
Chemical detective work is needed to track down what’s been killing e-cigarette users
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NewsDeaths from vaping-linked lung disease in US connected to vitamin E additive
Tocopheryl acetate implicated in 380 cases of severe lung disease and six deaths
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OpinionWill Novartis's data manipulation damage relations with regulators?
Trust between the two has been compromised
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NewsData manipulation casts shadows on Novartis gene therapy
Manufacturing problems with other new medicines highlight difficulty of developing advanced treatments
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OpinionIs this a golden age of new drug classes?
A host of new treatment modes are hitting the clinic and the market
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BusinessUS finalises guidance on biosimilars
Regulator clarifies requirements for allowing substitution between products
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NewsTelemedicine abortion provider locks horns with US drug regulator
Food and Drug Administration urged to take action against abortion charity by US politicians
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BusinessEmerging from the US opioid crisis
With litigation against suppliers in full swing, how does the US counter its addiction to powerful painkillers?
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NewsAs government shutdown drags on US researchers find themselves caught in the crossfire
As the shutdown enters its second month many scientists have been left struggling to pay the rent or childcare as research projects flounder
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BusinessPfizer to close two manufacturing plants in India
Closures will lead to the loss of 1700 jobs – almost 6% of the pharma giant’s manufacturing workforce