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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 January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
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 July 1, 2012 Jill Wechsler	Who Will Pay for New Drugs? Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies.
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 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 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 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 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 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 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 October 1, 2011 Jill Wechsler	At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system.
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 December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
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.
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, 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 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, 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 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 September 1, 2011 Richard Gliklich	The Power of Observation Observational studies present a compelling real-world corollary to the classic randomized clinical trial.
Investment Advisor December 2005 Greg B. Scott	Buying The Future Prudent investing in biotechnology can offer great returns for clients. It's also the wave of the future. Armed with a basic understanding of the dynamics of the industry and the valuation inflection points, intelligent investors can make significant returns.
Pharmaceutical Executive July 1, 2011 Jill Wechsler	Battles over Biosimilars Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game.
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 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.
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 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 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.
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?
Chemistry World July 2008 William Bains	Beyond shareholder returns The author offers a new model for the pharmaceutical industry
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 June 1, 2006 Nancy Dreyer	Personalized Medicine Meets the Real World A wave of genomic medicines is coming down the pipeline, and they're going to be expensive. Can companies prove they're worth it? Maybe: but the claims payers seek aren't coming from traditional clinical trials.
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.
Bio-IT World March 8, 2005 Patricia Reilly	Biomarkers: Trends and Potential Companies are centralizing biomarker research to help reduce spending.
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.
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 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, 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 May 1, 2006 Madison, Chan & Seeger	Making the Link The FDA recognizes that a new drug standard must evolve -- one of routine, proactive safety surveillance. But post-marketing safety studies are too slow. Here's how pharmaceuticals are using claims databases to solve the problem.
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 October 1, 2005 Patrick Clinton	From the Editor: No Substitutes Don't use surrogate measures in clinical drug trials, says a major industry critic. OK, but don't the critics base a lot of their points on surrogate measures, too?
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.
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, 2009 Jill Wechsler	FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order?
Pharmaceutical Executive May 1, 2009 Jill Wechsler	Compared to What? Pharma fears comparative effectiveness research will focus on costs and stymie personalized medicine.
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.
Bio-IT World December 15, 2003 Kevin Davies	The Road to Personalized Medicine FDA guidance on the road to genomic medicine is a welcome first step in what promises to be a contentious debate on how to integrate pharmacogenomics into routine medical practice.
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.
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.
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.