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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
July 1, 2013
Jill Wechsler
Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad. 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
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2005
Jill Wechsler
Washington Report: The e-Bandwagon The federal government is driving e-Rx adoption by establishing standards that Medicare drug plans will have to adopt by 2009, and HHS officials are pushing to make this happen much earlier. 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
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. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2013
Michele McGovern
Pharmacy Compounding: What's Ahead for Manufacturers Compounders are under increased scrutiny following last year's spinal meningitis outbreak. mark for My Articles similar articles
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. 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
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
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. 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
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
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
October 1, 2010
Getting Ready for Sunshine Health reform requires detailed tracking and full disclosure of fees to docs for marketing and research. mark for My Articles similar articles
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. 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
February 1, 2006
Bryan Luce
Back Page: Taking Hold of the Wheel Healthcare decision makers do not consistently consider drugs' value. FDA needs to be pressured to change its stance on communicating economic evidence. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2014
Jill Wechsler
Data disclosure, integrity challenge pharma Transparency initiatives are multiplying, affecting research, marketing and compliance. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
April 10, 2014
Obama Policies Reshape Pharma Marketing Health reform initiatives promote transparency, challenge reimbursement, writes Jill Wechsler. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2006
Jill Wechsler
Washington Report: After Plan B: Out of the Quagmire, into the Data The morning-after pill goes OTC, with some special requirements. But is FDA's drug information system up to the task of tracking how it is used? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
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
Pharmaceutical Executive
March 1, 2006
Jill Wechsler
Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too. mark for My Articles similar articles
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
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
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. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2007
Jill Wechsler
Washington Report: Shop and Compare Insurers and payers believe that more comparative information on medical treatments will save money and improve care, but such analysis may be costly to pharma. 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
BusinessWeek
June 26, 2006
Arlene Weintraub
Homegrown Hormone Therapy: How Safe? Popular alternatives to menopause drugs are under fierce attack by Wyeth and others. 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
January 1, 2009
Jill Wechsler
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? 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
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? mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2014
Jill Wechsler
What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2008
Jill Wechsler
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. 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
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
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. 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
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