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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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
March 31, 2008
Brian Lawler
FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
The Motley Fool
December 4, 2007
Brian Orelli
An Early Gift to Drugmakers Drugmakers could be allowed to market for drugs' off-label indications. mark for My Articles similar articles
The Motley Fool
December 2, 2010
Brian Orelli
A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
January 15, 2010
Brian Orelli
Oops, Sorry About That, Pfizer The FDA says there's no problem with Spiriva after all. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
April 28, 2011
Brian Orelli
Victory for Victrelis Merck's hepatitis C drug moves one step closer to FDA approval. mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
August 27, 2010
Brian Orelli
Down 35%! This Just Shouldn't Happen Someone's to blame and it isn't ImmunoGen. mark for My Articles similar articles
Pharmaceutical Executive
March 1, 2013
Al Topin
Less Selling, More Time What can happen when pharmaceutical reps focus on the physician-patient conversation? mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 31, 2009
Brian Orelli
2010 FDA Decisions to Watch It's a pivotal year for these drugmakers. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
December 31, 2010
Brian Orelli
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. mark for My Articles similar articles
The Motley Fool
April 5, 2010
Brian Orelli
1 Month to Go! Is Dendreon a Buy? Only if you understand the risks. 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
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
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
The Motley Fool
September 8, 2008
Rich Duprey
The Coming Great Pharma Panic The FDA's drug warning list provides dangerously little information. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
Science News
March 28, 2009
Science Past For March 28, 1959 Thoughts on patient resocialization in a mental hospital during the 1950s. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
The Motley Fool
October 11, 2010
Brian Orelli
FDA Rejection, but Still Jazzed Up Sometimes, biotechs are like that. mark for My Articles similar articles
The Motley Fool
November 29, 2010
Brian Orelli
There's Still Only One Merck KGaA's oral MS drug delay is Novartis' gain. mark for My Articles similar articles