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Pharmaceutical Executive
April 1, 2011
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. 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
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
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
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
December 1, 2012
Jill Wechsler
Obamacare, Innovation and Pricing Tax and budget decisions will shape the healthcare market and drug research and regulation. 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
Pharmaceutical Executive
December 1, 2008
Jill Wechsler
Challenge and Challenges Expanded healthcare coverage also fits the goals of pharma manufacturers. 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
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
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
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. 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
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
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
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
April 1, 2009
Jill Wechsler
Kickoff for Reform In addition to overhauling healthcare, Congress is weighing proposals for updating FDA policies and expanding access to drugs. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2009
Jill Wechsler
Securing Savings A close look at the healthcare industry will separate real cost-cutting measures from money-saving myths. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2012
Jill Wechsler
Costs and Benefits of Health Reform Will expanded markets and accountable care organizations offset higher rebates, added fees, and closer scrutiny of marketing and prices? mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2010
Jill Wechsler
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2012
Jill Wechsler
Costs, Coverage, and Court Decisions Its election season and drug pricing issues are once again front and center in the policy wars on managing the high cost of healthcare. 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
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. 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
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
October 1, 2011
Jill Wechsler
An 'A' for Advancing Expectations As head of both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, Mark McClellan has been at the center of public policy affecting the pharmaceutical industry over the last decade. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2013
Jill Wechsler
Washington Report: Innovation, Coverage, and Costs The backlash against high prices for new medicines will impact research, patent exclusivity, and drug benefits. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2014
Jill Wechsler
Drug Coverage, Costs Under Scrutiny Benefits offered by insurance plans on health exchanges and through Medicare are raising concerns about patient access to needed therapies 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
Chemistry World
March 25, 2010
Rebecca Trager
Big pharma scores in US healthcare reform President Obama has signed the biggest US healthcare reform since the 1960s, and although it is largely seen as a victory for the pharmaceutical industry, some analysts are characterising it as a 'double-edged sword'. 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
November 1, 2005
Jill Wechsler
Washington Report: Out of Commission? Crawford Steps Down The clouded circumstances of the commissioner of the Food and Drug Administration may complicate the process of securing a permanent leader. Meanwhile, battles continue over hot-button issues such as the morning-after pill and the regulation of follow-on biologics. mark for My Articles similar articles
Pharmaceutical Executive
August 1, 2013
Jill Wechsler
Costs and Coverage Challenge Medicare Drug Plans Rate cuts and fraud concerns create problems for Part D plans and Part B providers. 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
November 1, 2014
Jill Wechsler
Outrage Grows Over Drug Pricing Insurers, physicians attack high-cost therapies in anticipation of specialty drug surge. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2008
Jill Wechsler
Part D Under Attack Congressional leaders ready campaign to curb Medicare drug plans. 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
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. mark for My Articles similar articles
Pharmaceutical Executive
September 1, 2013
Jill Wechsler
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. 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, 2011
The Steep, Slow Climb A survey of leading experts reveals 2011's sobering reality and the trends that smart drugmakers will follow into the next decade. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2011
Jill Wechsler
"Representing" Healthcare to the Fullest Since coming to Congress about 35 years ago, Henry Waxman, Congressional Representative from Los Angeles, California, has been pivotal in shaping legislation on health and drug regulatory issues. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2007
Jill Wechsler
Washington Report: Medicaid Sets the Pace for Pharma Pricing Forget Medicare price negotiations. Pending changes in Medicaid drug-pricing formulas will put even more pressure on pharmaceutical prices. mark for My Articles similar articles
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 mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2009
Jill Wechsler
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
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