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BusinessWeek June 26, 2006 Arlene Weintraub |
Homegrown Hormone Therapy: How Safe? Popular alternatives to menopause drugs are under fierce attack by Wyeth and others. |
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 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. |
BusinessWeek January 8, 2007 Arlene Weintraub |
Is Your Medicine The Real Deal? Accusations are flying that some pharmacies substitute inferior versions of drugs. |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
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 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? |
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 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. |
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 September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. |
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 March 1, 2006 Jill Wechsler |
Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too. |
Reason Aug/Sep 2009 Jacob Sullum |
Cigarette Gag: Smokes and speech In April a bill was passed that includes a provision barring manufacturers from making any statement directed to consumers through the media that would reasonably be expected to result in consumers believing that the product is regulated and endorsed by the FDA |
Reason September 2005 Kerry Howley |
Locking Up Life-Saving Drugs U.S. prescription laws make us sicker and poorer because the system that puts drugs over the counter is driven by profits and patents. |
Food Processing February 2011 David Joy |
7 Things You Should Know About The New Food Safety Law Considered a win for consumers, the new law will have varying effects on food & beverage processors. |
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. |
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. |
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 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. |
The Motley Fool February 21, 2008 Brian Lawler |
A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin. |
BusinessWeek May 21, 2007 John Carey |
A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it? |
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 |
The Motley Fool January 28, 2005 Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous. |
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. |
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 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 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 1, 2009 Patrick Clinton |
Dear Commissioner... Unsolicited advice for FDA's next leader: Keep it real, fight popular delusions, and somehow, please, defend the agency. |
InternetNews June 13, 2005 Roy Mark |
Fake Canadian Drug Sites Proliferating New study shows 80 percent of sites claiming to be Canadian drug stores are registered in other countries. |
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 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. |
Pharmaceutical Executive July 3, 2007 Louis A. Morris |
Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way. |
Reason April 2001 Ronald Bailey |
Goddamn the Pusher Man Why does everybody seem to hate the pharmaceutical industry? |
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 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. |
Food Processing September 2010 Diane Toops |
Congress Scrambles to Pass Food Safety Legislation As Congress has argued over health care reform, financial reform, two wars, a mortgage crisis and unemployment, amending the U.S. food safety system was put on the back burner. |
Pharmaceutical Executive March 1, 2007 Jill Wechsler |
Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process. |
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. |
Managed Care April 2002 Paula Sirois |
HMOs Should Prepare Now To Get Handle on Injectables With more than 360 biotech products in the pipeline, high-cost injectable drugs are about to flood the market. How will we control the expenditure? |
HBS Working Knowledge September 24, 2007 Sean Silverthorne |
The FDA: What Will the Next 100 Years Bring? The challenge for FDA leaders is to maintain morale and focus, and to back up decisions with solid data on benefits and risks to different consumer populations. |
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. |
CIO March 15, 2006 Allan Holmes |
Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market. |
Pharmaceutical Executive September 1, 2006 Patrick Clinton |
From the Editor: Undecided People are buying drugs, because companies are selling drugs. Interfere with the selling process, and people won't buy as many drugs. |
Pharmaceutical Executive June 1, 2007 Clinton & Wechsler |
The View From Inside Commissioner Andrew von Eschenbach on drug safety, DTC advertising, FDA's culture, and how the agency plans to bring itself into the age of molecular medicine. |
Bio-IT World September 11, 2003 John Russell |
This Goose Is Better Uncooked From 'Poison Squad' to pharma watchdog, the ever-changing and controversial role of the FDA makes for fascinating history. |
Food Processing July 2005 David Joy |
Regulatory Issues: What's in a name? The Food and Drug Administration and the U.S. Dept. of Agriculture recently published a joint proposal to amend their regulations dealing with food "standards of identity." |
BusinessWeek May 3, 2004 John Carey |
Is Reimporting Drugs A Cheap Fix? Not Really Why reimporting drugs from Canada won't work in the long run |
Pharmaceutical Executive December 1, 2006 Richard A. Epstein |
FDA vs. the Individual In this excerpt from his important new book Overdose, an ever controversial legal scholar argues that the current system overvalues risk, ignores individual differences, and deprives patients of valuable treatments. |