All FDA articles – Page 3
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OpinionThe projects drug companies wish they’d never started
Failures are common in drug research, but some are bigger than others
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NewsJob satisfaction among US federal scientists decreases
Survey shows many researchers think staff cuts and politics interfere with their work
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FeatureFrom folklore to pharmacy
Although many drugs have in the past come from plants, Hayley Bennett discovers that it’s hard work getting them approved today
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BusinessDrugmaker blocks Nevada execution
Alvogen obtains a restraining order to delay US prisoner’s execution, saying Nevada state obtained its sedative midazolam via ‘subterfuge’
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NewsFears that US 'right to try' law could put patients at risk
Legislation will give terminally ill patients the option of taking medicines that have had little testing
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BusinessFDA new drug approvals more than doubled in 2017
The FDA approved 46 new drugs last year – the highest number in over two decades – due to factors like streamlined policies at the agency
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BusinessPharmaceuticals roundup 2017
Political influence has strongly shaped industry activity in the past year
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BusinessHurricane damage squeezes supply chains
Industry and government working to minimise impact of shortages of olefin feedstocks and medical products
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BusinessLong road to recovery for Puerto Rico pharmaceuticals
As inhabitants begin to rebuild their lives after the devastation of hurricane Maria, the island’s drug manufacturers are recovering slowly
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BusinessUS state passes law blocking generic drug price-gouging
Despite industry opposition, Maryland will be able to fine companies for ‘excessive and unjustified’ price increases
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BusinessUS probes opioid manufacturers
Attorneys general from 41 states will investigate companies over alleged fraudulent marketing and distribution of painkillers
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BusinessFDA warns Pfizer subsidiary over Epipen malfunctions
Manufacturer did not fully investigate reports of patients dying after auto-injector failures
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BusinessNovartis coasts towards first CAR-T approval
Unanimous recommendation for CTL019 ahead of October decision builds confidence in T-cell genetic reprogramming
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BusinessMallinckrodt settles US opioid lawsuit
Firm will pay $35m over allegations it failed to report suspicious orders of controlled substances
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BusinessFDA approves first sickle cell drug in almost two decades
Glutamine-based drug is the first approved for children over 5
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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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NewsLegal battles stall US biosimilars
Unclear legislation and lack of regulatory guidance means companies are turning to the courts
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OpinionDrug regulation is a burden worth bearing
Calls to break down regulatory barriers show a misunderstanding of the industry
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NewsFDA 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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OpinionRegulatory tightropes
When lobbying and marketing clash with scientific evidence, regulators walk a fine line