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Pharmaceutical Executive August 1, 2012 Jill Wechsler	Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act.
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 March 1, 2013 Jill Wechsler	Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year.
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin	Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
Pharmaceutical Executive January 1, 2012	Compliance: Getting Those Ducks in a Row Pharma must coordinate the efforts of medical, legal, HR, global partners and many other players in the regulatory compliance space to keep itself afloat in choppy seas.
Pharmaceutical Executive December 1, 2010 William Looney	In Through the Out Door The end of anther year is an appropriate time to highlight the march of time and the transitions that accompany it in Europe and in China.
Pharmaceutical Executive August 1, 2012 Ben Comer	Compliance Kulture: The Facts Behind GSK's CIA Big Pharma talks a lot about changing its business model to one that prioritizes quality and value over quantity and waste. How do you judge a sales rep's performance if not on how much she sells?
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
Pharmaceutical Executive January 1, 2012 Jill Wechsler	New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation.
Pharmaceutical Executive September 1, 2011 Jill Wechsler	Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.
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.
Pharmaceutical Executive September 1, 2011 Richard Gliklich	The Power of Observation Observational studies present a compelling real-world corollary to the classic randomized clinical trial.
Pharmaceutical Executive March 1, 2012 Ron Cohen	FDA's Necessary Dose of Reality There's no fast-acting salve, but there are several steps that can be taken to streamline many of the procedures at FDA. And it begins with leadership.
Pharmaceutical Executive July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
Pharmaceutical Executive February 1, 2013 Jill Wechsler	Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.
Pharmaceutical Executive November 1, 2013 Jill Wechsler	Transparency Troubles for Pharma High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise.
Chemistry World September 24, 2010 Andrew Turley	End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use.
Pharmaceutical Executive June 1, 2011	2011 Dealmakers Outlook With Yankee stadium as the backdrop, Pharm Exec convened on March 29 its annual panel of eight business development experts to crack the bat on best practice in licensing for the year ahead.
Pharmaceutical Executive January 1, 2011	The Steep, Slow Climb A survey of leading experts reveals 2011's sobering reality and the trends that smart drugmakers will follow into the next decade.
The Motley Fool April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
The Motley Fool March 15, 2010 Brian Orelli	FDA Says "No Way!" Market Says "Yeah, Baby!" You can have it both ways. The Food and Drug Administration's response wasn't exactly what investors in Amylin Pharmaceuticals, Eli Lilly, and Alkermes were looking for, but they'll take it.
Pharmaceutical Executive December 1, 2013	FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler.
Pharmaceutical Executive February 1, 2006 Jill Wechsler	Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system.
Chemistry World May 27, 2015 Phillip Broadwith	Label laundry It's been an interesting month in the world of off-label pharmaceuticals.
Chemistry World June 22, 2011 Sarah Houlton	US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
Pharmaceutical Executive March 1, 2012 Jill Wechsler	When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications.
Pharmaceutical Executive January 1, 2012 William Looney	Pharma 2012: Hard Times Before the Harvest 2012 will be a transition year for pharma, one of the most important in its history. The challenge is that many new treatments may not complete the move from 'bench to bedside' in time to plug the yawning revenue gap.
Pharmaceutical Executive August 1, 2013 William Looney	One Company -- One Moment The trade media is ablaze with lurid accounts of bribery, tax fraud, and other illicit promotional activities in China -- ironically, the country touted as guarantor of our industry's future.
Bio-IT World August 13, 2003 John Rhodes	Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert.
Pharmaceutical Executive June 1, 2006 Jill Wechsler	Washington Report: Promises to Keep Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
Chemistry World July 16, 2010 Matt Wilkinson	Bittersweet victory for GSK's Avandia GlaxoSmithKline has received a muted 'thumbs up' from a US regulatory advisory panel for its much-maligned Type 2 diabetes drug Avandia (rosiglitazone), making it likely the US Food and Drug Administration will allow the UK-based pharma giant to continue selling the drug in the US.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
The Motley Fool November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
Chemistry World December 22, 2010 Sarah Houlton	Fines, Flu and an Uncertain Future It was another tough year for the pharma industry, with downsizing, pricing concerns and the impending expiration of patents on many products. But some of the biggest headlines were caused by eye-watering fines dished out in the US.
Pharmaceutical Executive July 1, 2012 William Looney	The Learning Curve In a wake up call to this year's Emerging Leaders a group of St. Joseph's Business School Health Management alumni say time has no limit on surprises; change for pharma is here and it's good.
The Motley Fool October 5, 2010 Brian Orelli	You Should Have Seen this FDA Rejection Coming This hepatitis C treatment was marked for failure.
Pharmaceutical Executive December 1, 2010 Ansis Helmanis	A New Twist in the Cost Curve The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Is industry prepared to adapt or challenge?
Pharmaceutical Executive March 1, 2011 Jill Wechsler	New Tools Track Safety, Value in Medicine FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development.
Pharmaceutical Executive August 1, 2013 William Looney	Breaching the Great Wall With a revision of China's basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation.
Pharmaceutical Executive December 1, 2005 Patrick Clinton	PharmExec's 2006 Forecast The 2006 pharmaceutical industry is under assault from Congress, the press and the public, add a complex government program that will unimaginably change industry economics, and subtract revenues from off-patent products.
Pharmaceutical Executive January 1, 2011 William Looney	The Night Stalkers "Tops in Fraud" is a ruinous moniker for pharma -- a business so dependent on basic issues of trust, integrity, and quality.
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.
BusinessWeek December 13, 2004 John Carey	How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs.
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.
The Motley Fool January 19, 2011 Cliff D'Arcy	Glaxo Stung by Legal Bill GSK shareholders are hit by costly legal settlements.
The Motley Fool January 14, 2008 Brian Lawler	Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure.
Pharmaceutical Executive October 1, 2011 Jill Wechsler	"Representing" Healthcare to the Fullest Since coming to Congress about 35 years ago, Henry Waxman, Congressional Representative from Los Angeles, California, has been pivotal in shaping legislation on health and drug regulatory issues.