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Pharmaceutical Executive January 1, 2011 Roger L. Williams	Ensuring Drug Quality: A Complex Task in a Globalized Era With increasing globalization and longer and more complicated manufacturing supply chains, the quality and safety of our medicines is at much higher risk today than it was a decade ago.
Pharmaceutical Executive November 1, 2011 Roger L. Williams	Spotlight on OTCs With OTCs challenging traditional approaches to quality, new opportunities are arising to support industry innovation and advance public health.
Managed Care November 2004 John Carroll	Medicare Formulary Model Seen by Many as Too Inclusive The issue is how extensive the list of covered medications should be for the new Medicare pharmaceutical benefit. The stakes are enormous.
Managed Care February 2008 Martin Sipkoff	FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process?
Pharmaceutical Executive April 1, 2011	Off-Label But On Point? Use of off-label drugs is a balancing act for physicians, and poses even more problems for pharma. The FDA is moving slowly to help.
Pharmaceutical Executive February 1, 2006 Sarah Houlton	Global Report: Moving Towards Generic Biologics The European Medicines Agency hopes to complete its guidelines for the approval of biosimilar drugs early this year, paving the way for the approval of biogenerics - and a potential goldmine for the generics companies.
Pharmaceutical Executive September 1, 2011 Jill B. Conner	Complex Biologics: The View from Teva Industry and regulators alike must grapple with the sensitivities associated with developing bio-similar drugs.
Managed Care March 2008 Martin Sipkoff	The Epilepsy Battle in the War Between Brands and Generics Brand-name manufacturers and many neurologists see danger in generic substitution, but the FDA insists that the practice is safe
Managed Care June 2005 Martin Sipkoff	MMA Formulary Design Requires Health Plans To Control Costs Despite a mandate to adopt utilization management programs and make patients share costs, health plans are still lining up to participate in Medicare Part D.
Pharmaceutical Executive July 3, 2007	Thought Leader: Connected Markets, Rob Dhoble It used to be that pharma companies had one marketing strategy for the US and other developed nations, a second strategy for emerging countries, and a third, mostly focused around access, for the developing world. But in a global environment, that doesn't work.
Pharmaceutical Executive October 1, 2010	Taking a Less-Generic Route to Generics A leading pharmaceutical industry player speaks out on what is fueling success in the sector.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
Pharmaceutical Executive December 1, 2010	The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator The European Medicines Agency is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs.
Searcher June 2012 Stephanie C. Ardito	The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
Chemistry World July 25, 2012	Pharma Industry May Suffer as India Looks to Generics India plans to provide free generic drugs to half its population.
Chemistry World May 23, 2012 Andy Extance	Drug watchdogs mark out global territory The US Food and Drug Administration has published plans to ensure that American citizens continue to enjoy access to safe drugs, even as the regulatory pressures of globalization grow.
Pharmaceutical Executive November 1, 2011 Jill Wechsler	The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices.
Pharmaceutical Executive September 1, 2008 Jill Wechsler	Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches.
Chemistry World October 17, 2014 Dinsa Sachan	Indian manufacturers hit back over quality claims The Indian pharmaceutical industry has asked its government to sue authors of a study published by the US National Bureau of Economic Research in early September.
HBS Working Knowledge August 10, 2015 Michael Blanding	New Medical Devices Get To Patients Too Slowly The FDA has streamlined drug testing to ensure new therapies come to market quickly. But when it comes to life-giving medical devices, approvals seem unnecessarily slow, according to research by Ariel Dora Stern.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
Pharmaceutical Executive April 1, 2014 Subramanian et al.	"Market-Based" Price Controls In India? Three strategic implications for pharma pricing strategies in India.
Pharmaceutical Executive July 1, 2014 Jill Wechsler	Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.
Managed Care September 2003 Thomas Morrow	Managed Care Strategy: Create Competition In Expanding Biotech Field The biotech field is booming, and insurers are scrambling to find ways to deal with the high costs of new "biologic" treatments. One strategy is to try to create more competition among the producers of biotech drugs.
Managed Care February 2005	Medicare's Drug Coverage Seeks To Strike Compromise Health plan officials are still trying to determine just how the final rules for the new Medicare prescription drug benefit will affect them, because it appears that government officials tried their best to address the competing concerns of all players.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
The Motley Fool March 31, 2011 Brian Orelli	Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good.
The Motley Fool June 29, 2010 Brian Orelli	The Final Obstacle to Your Drug Company Multibagger The dreaded FDA advisory committee meeting.
Pharmaceutical Executive February 1, 2011 Jill Wechsler	Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency
Pharmaceutical Executive August 1, 2012	Sunny Outlook for Biopharm 2020? Albert Wertheimer looks beyond today's dark clouds with a comparatively sunny forecast for the biopharm industry in 2020. Just watch out for the harsh light of complacency.
Managed Care April 2007 Martin Sipkof	Abbreviated Approval Process In the Works for 'Biosimilar' Drugs The Access to Life-Saving Medicine Act may be a first step to giving the FDA the legal authority to approve these drugs.
Pharmaceutical Executive January 1, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
The Motley Fool March 23, 2010 Brian Orelli	No Patent! No Generics? Take Advantage of the Situation Enjoy it while it lasts, pharma.
Pharmaceutical Executive September 1, 2006 Jill Wechsler	Pharm Exec Q&A: A Soft Spot for Whistleblowers FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive interview, he explains where the agency goes wrong and what he would do to fix it.
The Motley Fool September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
Pharmaceutical Executive February 1, 2014 Jill Wechsler	Drug Coverage, Costs Under Scrutiny Benefits offered by insurance plans on health exchanges and through Medicare are raising concerns about patient access to needed therapies
Food Processing January 2005 David Joy	Regulatory Issues: The FDA agenda for 2005 As in the past, the FDA has a full agenda of food regulatory matters in 2005. So it's not good that the FDA's scientists are demoralized and the agency stands accused of being too friendly with a regulated industry.
Pharmaceutical Executive July 1, 2013 Jill Wechsler	Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad.
Managed Care April 2004 John Carroll	$50M for Drug Comparisons Could Produce Valuable Results The Medicare amendment adopted late last year contains a provision that could help P&T committees, not to mention consumers, evaluate competing drugs.
Pharmaceutical Executive April 1, 2006 Jill Wechsler	Washington Report: A Warning Trend Washington's new answer to drug safety concerns is more warnings and more disclosure of undigested data. But warnings can go too far. Haven't FDA's critics ever heard the story of the boy who cried wolf?
The Motley Fool November 30, 2010 Brian Orelli	A Witty Response to Pharma's R&D Dilemma According to GlaxoSmithKline CEO Andrew Witty, the pharmaceutical industry is a mess. That's the basic gist of his opinion piece in The Economist.
The Motley Fool October 16, 2006 Brian Lawler	The Coming Generic Drug Boom Generic drugmakers are poised to profit from several key factors. Investors, take note.
Chemistry World September 18, 2008 James Mitchell Crow	Ranbaxy hit by US drug ban The US Food and Drug Administration (FDA) has banned the import of more than 30 drugs made by Ranbaxy, India's largest drugmaker.
Chemistry World March 25, 2010 Rebecca Trager	Big pharma scores in US healthcare reform President Obama has signed the biggest US healthcare reform since the 1960s, and although it is largely seen as a victory for the pharmaceutical industry, some analysts are characterising it as a 'double-edged sword'.
Food Processing October 2009 Dave Fusaro	Food Industry 2010: Priorities for the New Decade From a new FDA to China, seven game-changers for 2010 and beyond.
BusinessWeek May 3, 2004 John Carey	Is Reimporting Drugs A Cheap Fix? Not Really Why reimporting drugs from Canada won't work in the long run
Managed Care February 2002 Bob Carlson	Proposal To Regulate Formularies Draws Sharp Difference of Opinion The National Association of Insurance Commissioners has spent two years developing a model. Drug companies like it; health plans don't...
Chemistry World September 17, 2010 Andrew Turley	Free trade could throttle generics from India International agreements on intellectual property threaten the flow of generic HIV drugs from India to developing countries, according to a new report.
Managed Care January 2008 John Carroll	Plans Look Askance at Me-Too Medications Tougher standards being applied by insurers spur debate about what constitutes true value in a new drug.