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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?
Pharmaceutical Executive March 1, 2009 Jill Wechsler	Through the Looking Glass Pharma relations with researchers are critical for developing new technology, and reformers will discourage inappropriate relationships by making any links to pharmaceutical marketing known to all.
Pharmaceutical Executive February 1, 2011 Jill Wechsler	The Building Block of Drug Discovery With Francis Collins now calling the shots at NIH, will be be able to deliver on the innovations behind the genome?
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.
Pharmaceutical Executive October 1, 2010	Getting Ready for Sunshine Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research.
Reason October 2007 Ronald Bailey	Is Industry-Funded Science Killing You? The overrated risks and underrated benefits of pharmaceutical research "conflicts of interest."
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, 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 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.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
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.
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.
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.
Chemistry World September 30, 2014	Transparency measures forced on pharma Previous misdemeanors are compelling the pharmaceutical industry to be more open with financial information and clinical data.
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 April 1, 2012	Special Section: Sunshine Act Still in the Shade Phase in of the Sunshine Act will force a reconsideration of the ethical consequences of all types of pharma meetings. How and to what extent remains to be seen.
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?
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 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 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.
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.
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 September 25, 2008 Brian Lawler	Eli Lilly's Dose of Disclosure The pharmaceutical pledges public reports of its dealings with doctors.
Pharmaceutical Executive March 1, 2014 Jill Wechsler	Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance.
Pharmaceutical Executive September 1, 2013 Jill Wechsler	Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies.
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 July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
Pharmaceutical Executive June 1, 2011 Jill Wechsler	Educating Physicians A communications program is the main component of a Risk Evaluation and Mitigation Strategy to promote safe use of extended-release or long-acting opioids, which have been the subject of FDA/industry negotiations for several years.
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 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.
Pharmaceutical Executive October 1, 2005 Lisa Grimes	Clear Road Ahead An industry standard for publicizing clinical-trial results is a ways off. But pharma's openness to more transparent procedures is moving things in the right direction.
Pharmaceutical Executive October 1, 2005 Andy Bender	Orchestrating Compliance Product managers at pharmaceuticals are not always happy to see their compliance officers. That may be changing.
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.
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.
Bio-IT World September 2006 Kevin Davies	The $2 Billion Pill? Challenges and opportunities facing the drug industry were recurring themes in the quartet of keynote speeches at the 2006 Drug Discovery Technology conference.
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.
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.
Pharmaceutical Executive September 1, 2005 Mattingly & Saxberg	Biomarkers Come of Age In the past five years, biomarkers have become an essential part of pharmaceutical R&D. Seven industry experts explain how it happened - and what comes next.
Pharmaceutical Executive June 1, 2014 Jill Wechsler	Compassionate Use Requests Complicate Drug Development Pharma, HCPs, and regulators walk tightrope in addressing early-access push while supporting biomedical R&D.
Pharmaceutical Executive April 1, 2011	White Coats & Suit Jackets: A Coming-of-Age Story The partnership between academia and industry is evolving. Will it keep innovation at a premium?
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 June 1, 2014 Jill Wechsler	What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices.
Pharmaceutical Executive September 1, 2013 Shantanu Agrawal	Making Sense of the Sunshine Act: A New Era for Drug Promotion Now that the Sunshine Act's Open Payments spending disclosure program is live, the federal government's lead officer for compliance explains how the new web-based system will work and how US industry, providers, and patients will be better off by making their relationships fully transparent.
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.
The Motley Fool May 11, 2010 Ryan McBride	Clinical Data Seeks to Challenge Lilly, Pfizer in Antidepressant Market The tiny drug developer has no problem going up against bigger rivals.
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 January 1, 2006 Jill Wechsler	Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin.
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 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.