All FDA articles – Page 4
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News
Review calls for tighter controls on antibiotic use in farming
Legally binding targets are needed to tackle resistance worldwide, latest report says
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News
Pepsi sets limit on caramel colouring chemical
Firm establishes legal threshold for the caramel food colouring by-product 4-MEI that California lists as a carcinogen
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Business
Merger fever sweeps pharma
The life sciences sector has been gripped by a mergers and acquisition frenzy, and it looks set to continue. But what does it mean for the industry?
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Business
US regulator reprimands Cepheid for norovirus diagnosis tool quality
Diagnostics firm has 15 days to respond to violations laid out by regulator
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Business
FDA takes action to remove biosimilars roadblock
The US Food and Drug Administration proposes system to name biosimilar drugs
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Business
Porous pills could be largest industrial 3D printing use
US grants first-of-a-kind approval for Aprecia’s epilepsy tablets exploiting porous structure
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News
FDA reverses debarment of one of its ex-chemists
US Food and Drug Administration lifts ban on chemist who worked at the agency, more than 20 years after he was sentenced for taking bribes
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Business
US import ban imposed on Indian pharma firm
Concerns over manufacturing processes at Emcure facility prompts Food and Drug Administration to block drug shipments
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Feature
Pharma queues up for checkpoint inhibitor collaborations
Combinations of different firms’ drugs seek to reap immuno-oncology’s benefits
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News
NIH plan to get drug development unit back online
The US National Institutes of Health to address deficiencies in unit that makes drugs for research studies
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News
NIH drug manufacturing unit shut down
The US National Institutes of Health suspends operations at its pharmaceutical development section after FDA inspectors uncover serious manufacturing issues
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News
California demands warning labels for BPA
Despite safety evidence, the state has added BPA to its list of cancer-linked chemicals under ‘Proposition 65’
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Business
Injunction blocks first US biosimilar
Despite regulatory approval, Amgen is delaying sales of Sandoz’s version of filgrastim
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Business
FDA accused of violating drug company’s freedom of speech
Amarin says the regulator is stopping it from giving ‘truthful, not misleading’ information to doctors about its fatty acid drug
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Business
Drug firms warned to be honest with investors
Official warns of ‘significant consequences’ if companies aren’t forthcoming about their FDA interactions
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Business
US approves biosimilar filgrastim
Sandoz’s version of Amgen’s Neupogen is ‘biosimilar’ but not ‘interchangeable’
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News
Caramel colour in soft drinks linked to cancer
Regulatory bodies and researchers sceptical of study on 4-MEI found in food colour
