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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, 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. 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
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
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
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
Chemistry World
October 23, 2013
Sarah Houlton
Pharma manufacturing woes dog industry Many problems arise from quality control failures, according to Nicholson Price from Harvard Law School's Petrie-Flom center for health law policy, biotechnology and bioethics, this is not the only problem -- regulatory constraints can prevent process improvements being made. 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
Chemistry World
December 22, 2011
Sarah Houlton
Pharma braces for patent cliff impact It remains to be seen quite how far Lipitor sales will fall. Ranbaxy has six months of exclusivity for generic competition. 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
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
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
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
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
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
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
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
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
Managed Care
June 2003
Joyce Ochs, MBA
Bar Coding: Old Technology To the Rescue Grocery stores and the nonpharmaceutical parts of drug stores have been using bar codes for years. Now retail and hospital pharmacies will use the technology to save lives. 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
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
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
Searcher
June 2012
Stephanie C. Ardito
The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations. mark for My Articles similar articles
Bio-IT World
August 13, 2003
Brian Reid
Remaking the FDA New commissioner is pushing for greater use of technology and innovation to speed the flow of drugs to market. mark for My Articles similar articles
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
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, 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
December 1, 2008
Jill Wechsler
Challenge and Challenges Expanded healthcare coverage also fits the goals of pharma manufacturers. mark for My Articles similar articles
Managed Care
February 2008
Martin Sipkoff
FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process? mark for My Articles similar articles
The Motley Fool
March 7, 2005
Brian Gorman
Glaxo in Hot Water Glaxo's problems with the FDA could have been avoided. Investors can only hope that the FDA is in a forgiving mood. mark for My Articles similar articles
Pharmaceutical Executive
April 1, 2006
Ron Feemster
Thought Leader: Q&A with Joel A. Tune Pharma still enlists contract manufacturers as safety valves, but today's drug developers have also begun to outsource the production of increasingly complicated compounds while they are still in clinical trials. 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
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
April 1, 2012
Feam & Lagus
Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can help. 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
December 1, 2005
Patrick Clinton
PharmExec's 2006 Forecast The 2006 pharmaceutical industry is under assault from Congress, the press and the public, add a complex government program that will unimaginably change industry economics, and subtract revenues from off-patent products. 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
June 1, 2014
dos Santos & Leskin
Social Media and the In-House Counsel Social media poses a regulatory and litigation maze that must be carefully navigated by pharmaceutical companies. 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
Pharmaceutical Executive
November 1, 2008
Patrick Clinton
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? mark for My Articles similar articles
The Motley Fool
September 10, 2004
Charly Travers
Looming Drug Shortages The push for drug re-importation into the U.S. will have consequences abroad. With supply restrictions in place, Canada and the U.K. are at a higher risk of drug shortages if pharmacies in those countries continue to sell drugs to U.S. citizens. mark for My Articles similar articles
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. 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, 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
April 10, 2014
Obama Policies Reshape Pharma Marketing Health reform initiatives promote transparency, challenge reimbursement, writes Jill Wechsler. mark for My Articles similar articles
BusinessWeek
December 13, 2004
John Carey
How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs. 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
Bio-IT World
January 21, 2005
How IT Can Decrease Time-to-Market in Clinical Trials Pharma manufacturers can learn from their industrial counterparts: Integrating systems can accelerate product delivery. mark for My Articles similar articles
The Motley Fool
January 31, 2007
Brian Lawler
FDA Says Hurray for More Drug Safety The FDA outlines its proposal to increase drug safety. Whatever the FDA does, pharmaceutical investors should hope that its renewed interest in drug safety doesn't make the already lengthy process of bringing drugs to market any longer. 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