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Bio-IT World April 2007 John Russell	Whatever Happened to the Critical Path? Science progresses at its own rate and medical science is necessarily more cautious than other branches. But it feels like the lack of money and mindshare are turning the FDA's Critical Path Initiative into just another umbrella project.
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?
Bio-IT World April 2006 John Russell	Lobbying for Critical Path Funding The FDA's Critical Path Initiative is an important program in need of cold hard cash and dedicated FDA personnel.
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.
Bio-IT World August 18, 2004 Anthony Strattner	Opportunity to Gain or Lose A keynote speaker at Best Practices ceremony asserts that drug-development science -- those activities that go beyond translational science and into product testing and commercialization -- has stagnated, causing a pipeline problem.
Bio-IT World August 13, 2003 Brian Reid	Remaking the FDA New commissioner is pushing for greater use of technology and innovation to speed the flow of drugs to market.
Pharmaceutical Executive May 1, 2006 Jill Wechsler	Washington Report: Opportunity Knocks FDA has finally released its long-awaited list of research opportunities for the Critical Path initiative. Now comes the hard part, as companies learn how to collaborate on projects that will benefit pharma as a whole.
Bio-IT World Jul/Aug 2006 Eric K. Neumann	Combining Drug Toxicity Knowledge Nearly half the drugs entering clinical trials will fail because of some form of serious toxicity that was missed in preclinical studies. These failures should not happen at such a late stage in the process. So what can be done?
Bio-IT World August 2005 Ellen H. Julian	Tech Expertise Singles Out Outsourcers Biopharmaceutical companies are flocking to consultants, outsourcers, and staffing firms to help with discrete clinical trial processes to gain access to advanced technologies and reduce the drain on already-scarce IT resources.
Bio-IT World August 18, 2004 John Russell	Special Report: 2004: A Best Practices Odyssey Grand Prize Winners: Drug Discovery & Development: Iconix Pharmaceuticals... IT Infrastructure & Informatics: Baylor College of Medicine, Department of Molecular and Cellular Biology Core Lab... etc.
The Motley Fool December 22, 2003 Alyce Lomax	Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired.
The Motley Fool June 12, 2007 Brian Lawler	Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg.
Bio-IT World Dec 2006/Jan 2007 Mark D. Uehling	CDISC Sees Growth in Standards Sponsors of clinical trials, large and small, are starting to see the wisdom in standards. That growing support was plain to see at the Clinical Data Interchange Standards Consortium's annual meeting.
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?
HBS Working Knowledge November 17, 2003 Martha Lagace	The Politics of Innovation Mark B. McClellan, the new commissioner of the Food and Drug Administration, described what the FDA is doing to bridge the gap between the high cost of innovation and patients' demand for lower prices.
Pharmaceutical Executive May 1, 2007 Weiner & Hovde	Critical Mass for Critical Path? Everyone agrees that it's the road to pharma's future, but no one's rushing to take it. Yet with growing FDA advocacy and new advances in biomarkers and drug-disease modeling, the rewards of collaboration now look greater than the risks.
The Motley Fool December 27, 2011 Brian Orelli	2011 No Dreamboat for MannKind An FDA rejection and a long wait is a bad combination.
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.
Bio-IT World June 12, 2002 Malorye Branca	FDA Fosters Pharmacogenomics One reason pharmaceutical companies have been slow to embrace pharmacogenomics is the fear that it will be difficult to get such products through the FDA. Lawrence J. Lesko, director of the FDA's Office of clinical pharmacology and biopharmaceutics, talks about his hopes for the field.
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
Pharmaceutical Executive January 1, 2007	Thoughtleader: Peter Pitts. DrugWonks.com Here, the chief voice of a blog hosted by the non-profit Center for Medicine in the Public Interest urges pharma to continuously plug its positions and get politics out of science, and offers some perspective on important regulatory reforms facing the FDA.
Bio-IT World December 15, 2003 Mark D. Uehling	Model Patient Despite the FDA's new support for computational modeling, the pharmaceutical industry remains cautious about simulating clinical trials.
Bio-IT World March 8, 2005 Patricia Reilly	Biomarkers: Trends and Potential Companies are centralizing biomarker research to help reduce spending.
The Motley Fool February 22, 2011 Brian Orelli	A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S.
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.
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.
The Motley Fool January 29, 2008 Brian Lawler	Acorda Rides the Wave Acorda Therapeutics announces positive clinical trial data on its lead multiple sclerosis drug.
Pharmaceutical Executive August 1, 2008 Jill Wechsler	Can Sentinel Save Drug Development? FDA's new sentinel system shows the pendulum swing toward safety won't swing back anytime soon.
Chemistry World May 2007 Derek Lowe	In the Pipeline After months of bleak news about faltering pipelines and redundancies, it's time to find reasons to be cheerful about the drug industry.
Pharmaceutical Executive September 1, 2005 Jill Wechsler	Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency.
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.
The Motley Fool January 20, 2011 Brian Orelli	This Stock Is No Dreamboat The FDA is not kind to MannKind.
Pharmaceutical Executive November 1, 2008 Jill Wechsler	Resolving Conflicting Interests The Physician Payment Sunshine Act would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors.
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
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 September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
Chemistry World January 2008 Derek Lowe	Column: In the Pipeline It's been a rough year, but the future looks bright for pharma.
Bio-IT World September 2005 Mark D. Uehling	Murky Diary Entries The FDA is planning to clarify the degree to which existing patient diary technologies are (or are not) encroaching on data-management duties formally assigned to clinical investigators. That guidance is in the works, with no known timetable.
The Motley Fool January 16, 2008 Brian Orelli	Headache Almost Over for Pozen The drug is safe; hopefully that's all the FDA wanted to know.
The Motley Fool April 14, 2008 Brian Orelli	Stem Cells Show Off The FDA moves closer to setting up stem cell clinical trials, setting guidelines that put treatment safety first and foremost.
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.
The Motley Fool July 29, 2010 Brian Orelli	This FDA Panel Isn't Brilliant Why does AstraZeneca's blood thinner Brilinta work better outside the U.S. than here at home? The Food and Drug Administration's advisory panel didn't seem to have a good explanation, but they didn't appear to care much, either.
The Motley Fool May 15, 2008 Brian Lawler	You're Kidding Me, Cardiome! Canadian pharmaceutical company Cardiome is still awaiting an FDA decision on its lead drug.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
The Motley Fool December 31, 2007 Brian Lawler	Lower Expectations for Theravance The FDA decides to debate Theravance's lead drug, Telavancin, leading to a drop in share price.
Chemistry World September 2007 Derek Lowe	Column: In the Pipeline Will Phase Zero trials actually help drug development?
The Motley Fool December 8, 2006 Brian Lawler	Medarex Takes the Fast Route Medarex's lead drug gets an important yet expected designation from the FDA. Making a pharmaceutical company investment-worthy requires success in the clinic and the laboratory, but it also mandates that companies handle their finances correctly.
Bio-IT World March 17, 2004 Zachary Zimmerman	Testing Times for the FDA The FDA's pharmacogenomic guidance marks the beginning of a long process toward standardized tests.
The Motley Fool December 8, 2011 Luke Timmerman	Affymax Passes FDA Panel Scrutiny, Looks to Challenge Amgen Anemia Drug Many investors wrote off Affymax in June 2010, but was that premature?
Reason April 2004 Todd Seavey	Regulation for Dummies A book about the FDA.