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Browse Patient package inserts topic

Laws, regulations and rules subtopic

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1-30 out of 30 article(s)
Title Author Type Date Words
Overdosing on authority: negative side effects of the FDA's proposal for generic label changes may include increased costs and liabilities. Santoro, Cassandra L. Jan 1, 2016 11099
Q&A with the FDA: implementing the PLLR. Interview Sep 1, 2015 924
Too good to last? Will the FDA's proposed rule put an end to generic drug preemption under Mensing and Bartlett? Diab, Tony M. Jan 1, 2015 6799
Problems found with the quality and labeling of some 'muscle enhancemen' supplements. Oct 1, 2014 484
New FDA rule on drug labeling may mean increased exposure and an uncertain path for generic pharmaceutical manufacturers. Matthews, James W.; Koski, Katy E.; Hinkle, Michael H.; Drori, Jason L. Reprint Jul 1, 2014 2805
Lunesta changes. Jun 2, 2014 109
Label change for long-acting opioid drugs ordered. Brief article Nov 1, 2013 110
A First Amendment approach to generic drug manufacturer tort liability. Sullivan, Connor Nov 1, 2013 6782
Drug safety communications: principles, practice, and evaluation. Eby, Michelle Dec 1, 2012 1105
FDA adds new safety warnings to statins. Jul 14, 2012 438
Pliva, Inc. v. Mensing: how generic-drug manufacturers avoided liability for "failure to warn" tort claims. Feeney, Gregory J. Mar 22, 2012 8374
Watchdog urges drug warnings. Anderson, Jane Brief article Sep 15, 2011 145
Off-label use of medications. Report Sep 15, 2011 906
FDA preemption of drug and device labeling: who should decide what goes on a drug label? Valoir, Tamsen; Ghosh, Shubha Mar 22, 2011 19955
Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers. Rostron, Allen Feb 1, 2011 30757
Beyond the boundaries. Jan 1, 2011 1125
N.Y. aims to standardize prescription instructions. Aug 30, 2010 340
Suicide added to tramadol label. Jun 15, 2010 148
Benzoyl peroxide ruled safe after years of debate. Ault, Alicia Brief article Apr 15, 2010 210
Benzoyl peroxide declared safe. Brief article Apr 15, 2010 145
Plavix not for poor metabolizers. Brief article Apr 1, 2010 129
FDA demands tougher labeling for long-acting beta-agonists. Mechcatie, Elizabeth Mar 15, 2010 520
FDA to Change Labeling for Long-Acting Beta-Agonists. Mechcatie, Elizabeth Mar 1, 2010 540
Sight unseen; the challenges of Braille height and the new EU directive 2001/83/EC Article 56A for the pharmaceutical industry are reviewed. Abraham, David Jan 1, 2010 1069
Propoxyphene gets boxed warning. Brief article Aug 1, 2009 249
New labels for painkillers. May 25, 2009 470
FDA requires additional labeling for OTC pain relievers and fever reducers. Brief article Apr 28, 2009 180
Rx package inserts: redesigned with fewer errors in mind: the first PI makeover in 25 years adds "highlights" and adverse event hotlines. Fass, Jennifer A.; Seamon, Matthew J.; Cytacki, Jacqueline Jun 1, 2007 1645
RX groups fight MedGuide. Mar 11, 1996 725
From prescription to over-the-counter: watered-down warnings. Rheingold, Paul D. Mar 1, 1996 2827

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