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Pharmaceutical Executive April 1, 2007 Patrick Clinton |
From the Editor: Taking It Outside FDA Commissioner Andy von Eschenbach said something pretty reasonable, and in return received a blistering, menacing letter from Senator Charles Grassley -- a letter that showed yet again that Grassley just doesn't understand what he's destroying in his campaign against FDA. |
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. |
The Motley Fool December 31, 2007 Brian Lawler |
Does Leadership Count at the FDA? Let's take a look at how drug approval rates have fared under different FDA commissioners. |
The Motley Fool March 31, 2008 Brian Lawler |
FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog. |
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 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. |
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. |
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 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. |
The Motley Fool December 4, 2007 Brian Orelli |
An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications. |
The Motley Fool December 2, 2010 Brian Orelli |
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. |
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. |
The Motley Fool January 15, 2010 Brian Orelli |
Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all. |
The Motley Fool June 3, 2011 Luke Timmerman |
Orexigen, Facing High Hurdle at FDA, Puts Obesity Drug Development on Hold The close attention paid to safety makes this drug difficult to get right. |
The Motley Fool January 11, 2011 Brian Orelli |
A Clear Drug-Development Path -- Times 2 The FDA throws a fork in the road for Isis and Genzyme. |
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 April 25, 2011 Luke Timmerman |
Vertex, Merck Step Up to the Public Stage With Hepatitis C Drugs This Week Most analysts see Vertex's drug as best-in-class. But what does the FDA have to say about it? |
The Motley Fool April 28, 2011 Brian Orelli |
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. |
Pharmaceutical Executive September 1, 2012 Al Topin |
Doctors' Words No Longer Gospel In the digital age, physicians don't call the shots when it comes to healthcare guidance. Marketers must appeal to multiple sources in seeking ways to garner patient adherence and loyalty. |
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. |
Food Engineering January 1, 2009 |
Regulatory Watch: Improved FDA plan for food protection Under increasing criticism for its oversight of the nation's food supply, FDA issued a plan to better protect food from accidental and intentional contamination. |
The Motley Fool January 8, 2008 Brian Orelli |
A Painful Reminder From the FDA The agency issues a reminder that osteoporosis drugs can cause severe pain. |
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. |
The Motley Fool August 27, 2010 Brian Orelli |
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. |
Pharmaceutical Executive March 1, 2013 Al Topin |
Less Selling, More Time What can happen when pharmaceutical reps focus on the physician-patient conversation? |
Pharmaceutical Executive January 1, 2007 |
Thoughtleader: Peter Pitts. DrugWonks.com Here, the chief voice of a blog hosted by the non-profit Center for Medicine in the Public Interest urges pharma to continuously plug its positions and get politics out of science, and offers some perspective on important regulatory reforms facing the FDA. |
Managed Care March 2005 Martin Sipkoff |
Direct-to-Consumer Ads Garner Mixed Outcomes DTC advertising's reputation as a bully may be largely overstated. There's little evidence that sales of specific drugs increase, and there may be some benefit. |
The Motley Fool December 3, 2010 Travis Hoium |
Orexigen Therapeutics Shares Plunged: What You Need to Know Shares of biopharmaceutical company Orexigen Therapeutics fell 10% today after a Food and Drug Administration announcement. |
Pharmaceutical Executive January 1, 2013 Al Topin |
The Doctor-Patient Disconnect Doctor-patient conversations aren't always what we think; this basic interaction represents both a problem and an opportunity for today's drug marketers, says the author. |
Chemistry World September 24, 2010 Andrew Turley |
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use. |
The Motley Fool December 31, 2009 Brian Orelli |
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. |
CIO September 27, 2013 |
How IT Can Produce Better Patient Care For Dr. Bob Laskowski, president and CEO of Christiana Care Health System, technology means empowering physicians and patients. |
The Motley Fool June 3, 2011 Brian Orelli |
FDA Bullies Obesity Drugmakers It's been clear for some time that the Food and Drug Administration isn't particularly fond of obesity drugs. Now it's just being a bully. |
The Motley Fool February 23, 2005 Stephen D. Simpson |
Take Two on COX-2 FDA panel recommendations breathe new life into Merck and Pfizer's COX-2 pain medications. Looking ahead, investors should give a good, long look to the drug sector. |
The Motley Fool December 31, 2010 Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool April 5, 2010 Brian Orelli |
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. |
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. |
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. |
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. |
The Motley Fool September 8, 2008 Rich Duprey |
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. |
The Motley Fool September 9, 2010 Brian Orelli |
Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September. |
Pharmaceutical Executive July 1, 2011 Cabacungan & Clark |
New Ways to Gain New Brand Insights If you can learn to understand patient and physician behavior, you are well on your way to strengthening the position of your product. |
Science News March 28, 2009 |
Science Past For March 28, 1959 Thoughts on patient resocialization in a mental hospital during the 1950s. |
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 March 31, 2011 Brian Orelli |
Drug Warning Labels: The Good, Bad, and Ugly Once a drug is approved, investors can't fall asleep and ignore FDA announcements about drugs. They come in different varieties, but warnings tend to be of the bad and ugly variety more often than the good. |
The Motley Fool April 26, 2011 Luke Timmerman |
FDA Says Vertex Drug a Wee Bit More Effective Than Advertised; Stock Climbs Good news for Vertex? |
Food Processing October 2008 Diane Toops |
A Conversation with Food Safety Czar David W.K. Acheson A exclusive conversation with `food safety czar' David W.K. Acheson, FDA's Associate Commissioner for Foods. |
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? |
The Motley Fool October 11, 2010 Brian Orelli |
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. |
The Motley Fool November 29, 2010 Brian Orelli |
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. |