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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 October 1, 2010 |
Getting Ready for Sunshine Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research. |
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 November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
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 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. |
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 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. |
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 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 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 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, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
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, 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 October 1, 2012 Jill Wechsler |
Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny. |
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 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 March 1, 2014 Jill Wechsler |
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance. |
Pharmaceutical Executive February 1, 2012 Engelmann & Geetter |
Tightening the Compliance Net A dissection of the new Sunshine regulations in the Affordable Care Act |
Pharmaceutical Executive September 1, 2008 Melanie North |
Publish or Perish FDAAA means that companies need to register clinical trials; and not only for publication planning. |
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 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 June 1, 2005 Jill Wechsler |
Washington Report: "D" Is for Data It is critical for Medicare to address important questions on drug safety and utilization, and about how prescribing decisions affect health outcomes and costs. |
Pharmaceutical Executive December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes |
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. |
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 January 1, 2013 Jill Wechsler |
Transformation to Characterize 2013 FDA policies will reshape drug development, while pressure to cut healthcare spending may alter drug coverage and pricing. |
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 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 April 10, 2014 |
Obama Policies Reshape Pharma Marketing Health reform initiatives promote transparency, challenge reimbursement, writes Jill Wechsler. |
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 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 July 1, 2013 Jill Wechsler |
Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad. |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
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? |
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 September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
Pharmaceutical Executive January 1, 2013 Kenneth Getz |
The Scoop on Drug Shortages New research sheds fresh light on a trend with serious consequences for the public health; not only in the United States but for patients worldwide. |
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 June 1, 2007 Dinh Nguyen |
Clinical Trials Under Scrutiny Over the last few years, there has been a growing number of instances of misconduct in clinical research. |
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 August 1, 2008 |
Harbingers of Change The pharmaceutical industry is changing. Here are eight seminal events that describe how. |
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 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 May 1, 2011 Jill Wechsler |
Outrage Over Drug Prices Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies |
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. |
Bio-IT World March 8, 2005 Mark D. Uehling |
Is That a Target on Her Back? Q&A with Deborah Zarin, head of ClinicalTrials.gov, the matchmaking Web site for patients seeking to participate in federally sponsored clinical trials. |
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 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. |