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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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
July 30, 2007
Jill Wechsler
Washington Report: Exclusivity vs. Patents To encourage innovation while supporting access to less costly therapies, Congress proposes an extensive data-exclusivity period that would delay Food and Drug Administration approval of a follow-on biologic application for 12 years. mark for My Articles similar articles
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. mark for My Articles similar articles
BusinessWeek
April 18, 2005
Making Those Pills Safe For Kids Few medicines get tested on children. Dr. Donald Mattison is pushing to change that. mark for My Articles similar articles
Managed Care
July 2005
Martin Sipkoff
Support Grows for Establishing National Clinical Trial Registry Stakeholders are pushing for a national clinical trial registry, and efforts by UnitedHealth Group are in the forefront. Medical journals are setting hard and fast rules. mark for My Articles similar articles
Salon.com
May 23, 2002
Lawrence H. Diller
A prescription for disaster The failure to test the effects in children of routinely prescribed drugs has resulted in at least one death. How many kids will die before drug companies take steps to ensure their safety? mark for My Articles similar articles
Reason
September 2005
Kerry Howley
Locking Up Life-Saving Drugs U.S. prescription laws make us sicker and poorer because the system that puts drugs over the counter is driven by profits and patents. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2007
Jill Wechsler
Washington Report: Pathways for Proteins The push is on to establish an approval pathway for generic versions of biotech therapies. Innovators want exclusivity and clinical studies for follow-on biologics, but visions of billion-dollar savings may short-circuit the scientific debate. mark for My Articles similar articles
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. mark for My Articles similar articles
Reason
October 2007
Ronald Bailey
Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest." mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
CIO
March 15, 2006
Allan Holmes
Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2011
Jill Wechsler
Outrage Over Drug Prices Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies mark for My Articles similar articles
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. mark for My Articles similar articles
American Family Physician
December 1, 2000
William M. Rados
Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities... mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2005
Sarah Houlton
Global Report: Kids 'R' EU After years of delay, the European Parliament is ready to vote on pediatric-testing legislation. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2009
Jill Wechsler
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2011
Jill Wechsler
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2014
Jill Wechsler
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2011
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. mark for My Articles similar articles
BusinessWeek
May 21, 2007
John Carey
A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it? mark for My Articles similar articles
The Motley Fool
February 16, 2010
Brian Orelli
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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'. mark for My Articles similar articles
The Motley Fool
April 26, 2011
Luke Timmerman
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2011
Jill Wechsler
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. mark for My Articles similar articles
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. mark for My Articles similar articles
Chemistry World
August 23, 2012
Dean Baker
Monopoly money It is remarkable that the system of patent support for prescription drug research has not become more of a policy issue. mark for My Articles similar articles
The Motley Fool
February 24, 2011
Brian Orelli
Youth in Revolt Against POZEN POZEN fails to get a pediatric extension on its migraine drug. mark for My Articles similar articles
The Motley Fool
December 12, 2007
Brian Lawler
Patent Bill Is No Panacea A new bill that was meant to strengthen the patent and other intellectual-property rights of drugmakers doesn't do enough to encourage pharma innovation. mark for My Articles similar articles
Salon.com
March 9, 2000
Lawrence H. Diller, M.D.
Kids on drugs A behavioral pediatrician questions the wisdom of medicating our children. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2006
Jill Wechsler
Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin. mark for My Articles similar articles
Pharmaceutical Executive
May 1, 2005
Jill Wechsler
Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment. mark for My Articles similar articles
Pharmaceutical Executive
July 30, 2007
Louis A. Morris
Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2012
Jill Wechsler
Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors. mark for My Articles similar articles
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. mark for My Articles similar articles
Managed Care
September 2004
Thomas Morrow
Orphan Drug Act Treatments Deserve Full Insurance Coverage An important federal law encourages development of drugs for populations so small that the market would otherwise ignore them. Should they not then be covered? mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2012
Jill Wechsler
Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2007
Jill Wechsler
Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process. mark for My Articles similar articles
The Motley Fool
July 30, 2010
Brian Orelli
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
January 28, 2005
Karl Thiel
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. mark for My Articles similar articles