All FDA articles – Page 3
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BusinessFDA asks Endo to take pain drug off market
Request part of larger strategy to address opioid misuse in the US
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News
Legal battles stall US biosimilars
Unclear legislation and lack of regulatory guidance means companies are turning to the courts
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Opinion
Drug regulation is a burden worth bearing
Calls to break down regulatory barriers show a misunderstanding of the industry
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News
FDA inspection data on nearly 1,000 overseas drug firms is missing
80% of US drug ingredients now come from abroad, yet challenges remain in FDA oversight of foreign drug firms
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Opinion
Regulatory tightropes
When lobbying and marketing clash with scientific evidence, regulators walk a fine line
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Business
Troubled Theranos abandons clinical testing
Seeking to salvage some value, once-admired blood analysis firm lays off 40% of staff
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Business
FDA’s first Duchenne drug approval reveals schism
Oligonucleotide drug reaches market amid pressure from patient families and strife over ‘patient-focused drug development’ at the regulator
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News
US agency bans triclosan and 18 other antibacterials
The FDA has banned 19 antimicrobials in the US and given industry a year to remove them from consumer products
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Business
FDA urges labs to test all blood donations for Zika
Agency has also given emergency authorisation to two new Zika blood tests
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Business
Juno CAR-T trial suspended after patient deaths
Immunotherapy study restarted with amended pre-treatment protocol
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Opinion
Time for better incentives to keep drug costs low
Getting outraged at drug price hikes is all very well, but we need more constructive options
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Business
Jazz Pharma buy out Celator in $1.5bn deal
Deal centres on promising leukaemia drug fast-tracked by the US Food and Drug Administration
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Business
India hit hard by US regulatory sanctions
Data integrity issues have led to punitive measures, but companies are taking measures to improve
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News
US drug giant will no longer supply lethal injection drugs
With Pfizer’s exit no US-approved pharma firm will sell its drugs to be used in executions
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Business
FDA moves to withdraw swine drug carbadox
Carcinogenic antibiotic has been banned in EU, Canada and Australia for years
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News
US food and drug agency finally gets new head
The Senate has approved a new administrator for the Food and Drug Administration after months of delay and opposition
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Business
Merck & Co joins hepatitis C party
New drug adds new treatment options and increases competition in premium market
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News
US bans three food packaging chemicals
Food agency prohibits the use of three perfluorinated compounds linked to cancers in food-contact materials
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