All FDA articles – Page 6
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Business
Generics giants jostle over pain drug
Mylan and Actavis contest Teva’s generic celecoxib exclusivity
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Business
Boehringer to settle blood thinner drug suits for $650m
Company confident in drug safety but says court cases are too risky
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Business
Contamination troubles strike GSK
GlaxoSmithKline is warned over contamination at an Ireland plant, and has recalled Alli from US retailers over tampering concerns.
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Business
US focuses pharma supply chain scrutiny
Import pre-authorisation for trusted firms frees up resources to tackle purity problems
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NewsPoliticians accuse US food agency of illegally monitoring employees
Republican staff report calls the Food and Drug Administration’s surveillance of whistleblowers unlawful
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Business
US blocks imports from fourth Ranbaxy plant
FDA bans import of active ingredients from factory in Toansa, India
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NewsFDA wants the dirt on antibacterial soaps
US manufacturers will have to prove their products are safe and more effective than ordinary soap, under a proposed rule
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Opinion
Cut price pills cost more than pennies
We can’t afford to let the demand for cheaper medicines force compromises on quality, says Steven Ford
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BusinessNew wave of hepatitis C drugs hits US shore
J&J’s once-daily drug approved by FDA, but rivals are hot on its heels
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Business
US turnaround on Avandia restrictions
Researchers accuse regulator of face-saving U-turn over diabetes medication safety
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Business
Regulator cracks down on 23andMe
Personal genetic profiler ordered to stop selling DNA test kits
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BusinessPharma manufacturing woes dog industry
Regulators are stepping up inspections, and discovering ever more problems
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Business
Roche backs biologics boom
Swiss firm to invest heavily in manufacturing for complex biological drugs
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Business
First biosimilar antibody drugs approved in Europe
European commission gives final approval to generic infliximab copies
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NewsExecution drug cannot be imported into US
Court rules that the Food and Drug Administration acted unlawfully allowing sodium thiopental into the country
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Business
Big data to sniff out drug marketing fraud
US Food and Drug Administration wants to track promotional spending to spot off-label marketing
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Business
Two new ‘personalised’ cancer drugs approved
Suitable patients for GSK’s melanoma treatments must be identified using an accompanying genetic test