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BusinessWeek February 9, 2004 John Carey |
Drug Ads Need Stronger Medicine New FDA guidelines may not go far enough in making sure pharmaceutical ads are used appropriately. |
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. |
Pharmaceutical Executive July 30, 2007 Louis A. Morris |
Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages. |
Pharmaceutical Executive January 1, 2006 Lou Morris |
Back Page: Nailing Down DTC Promotion Before the FDA and industry can find a solution to direct to consumer promotion, they need to nail down the problem. |
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. |
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 April 1, 2006 Diane West |
Media Spend Trends: Change the Channel Drug marketers still spend lots of money. But they aim at PhRMA loopholes. |
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. |
Pharmaceutical Executive January 1, 2006 Kenneth I. Kaitin |
Opinion: Memo to von Eschenbach FDA's acting commissioner has an opportunity to clarify a lot of misconceptions about the agency's role in regulating drug safety. His first order of business should be to explain exactly what FDA doesn't do. |
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. |
American Family Physician February 15, 2006 Liz Smith |
Newsletter FDA Announces New Prescription Drug Information Format... ASTM International Develops Continuity of Care Record... HHS Launches Project to Test Electronic Prescribing for Medicare Part D... etc. |
BusinessWeek March 7, 2005 John Carey |
Side Effects Of The Drug Scares New fears give rise to a more honest look at the risks for a pill-popping nation. |
Pharmaceutical Executive April 1, 2007 McCook & Daniels |
Making the Switch More companies are using Rx-to-OTC switches to extend a brand's life cycle. Prilosec did it. Here, experts dish on how you can do it too. |
Pharmaceutical Executive November 1, 2012 Sue Barrowcliffe |
Real World Insights Commercial teams as well as patients can benefit from managed access programs, which are designed to provide access to medicines outside of the clinical and commercial setting, for patients who have no other available treatment options. |
Pharmaceutical Executive August 1, 2014 Jill Wechsler |
Social Media Struggles Continue Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world. |
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. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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. |
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. |
The Motley Fool August 22, 2007 Brian Orelli |
Regulating the Drug Pushers The FDA might get a little tougher on drug ads, following a report that they may not be watching advertisers claims closely enough, or warning patients about side effects strongly enough. |
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. |
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. |
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. |
Reason Aug/Sep 2007 Kerry Howley |
Dying for Lifesaving Drugs Will desperate patients destroy the pharmaceutical system that produces tomorrow's treatments? |
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. |
HBS Working Knowledge November 17, 2003 Martha Lagace |
The Politics of Innovation Mark B. McClellan, the new commissioner of the Food and Drug Administration, described what the FDA is doing to bridge the gap between the high cost of innovation and patients' demand for lower prices. |
American Family Physician December 1, 2000 William M. Rados |
Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities... |
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. |
BusinessWeek November 19, 2009 Catherine Arnst |
Why Drugmakers Don't Twitter The FDA has so far failed to craft rules clarifying how pharmaceutical companies can participate in online discussions. |
The Motley Fool September 8, 2008 Rich Duprey |
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. |
Pharmaceutical Executive March 1, 2006 Lou Morris |
Backpage: Warning Letter A press release describes the existence of a new Patient Counseling Information section. Drug labels have contained a patient information section within the precautions section. The suggestion that this section is new is false and misleading. |
Chemistry World July 2007 Victoria Gill |
Conflict of interest? The FDA has been questioned after a published study brought exposed cardiovascular risks associated with GlaxoSmithKline's diabetes drug, Avandia. |
Fast Company February 2014 Jeff Chu |
Apple Retail at a Glance Facts and figures about Apple retail numbers. |
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 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, 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. |
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. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
BusinessWeek April 25, 2005 Catherine Arnst |
When Patients Say: Don't Ban My Drug Emotional lobbying can keep a treatment on the market despite serious side effects. |
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? |
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? |
The Motley Fool January 14, 2008 Brian Lawler |
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. |
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 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. |
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? |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
Information Today January 29, 2001 Susan Detwiler |
Drugfacts.com Portal Launched to Fill a Niche On December 4, 2000, Wolters Kluwer International Health & Science introduced DRUGFACTS.com, a new portal aimed at pharmacists and drug information professionals... |
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 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. |