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Pharmaceutical Executive
June 1, 2007
Patrick Clinton
From the Editor: Not His Problem In the current climate, who's going to get doctors to take on the work of making good decisions and occasionally the responsibility for having made a bad one? 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
Chemistry World
February 3, 2012
Rebecca Trager
Whistleblowers accuse FDA of spying, persecution The US Food and Drug Administration is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. 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
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
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
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
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
Chemistry World
March 6, 2014
Rebecca Trager
Politicians accuse US food agency of illegally monitoring employees Republican leaders on two key congressional committees have concluded in a new report that the US Food and Drug Administration illegally monitored email communications sent by whistleblowers in the agency. 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
December 28, 2010
Brian Orelli
Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson. 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
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
The Motley Fool
February 25, 2011
Brian Orelli
When the Companies Know, Investors Should, Too Why don't more companies preannounce FDA rejections? 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
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. 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
The Motley Fool
September 18, 2007
Brian Orelli
PDUFA Reauthorization: Almost There Much to the applause of drug makers and those who invest in them, the Prescription Drug User Fee Act reauthorization looks like it could come out of a Congressional conference committee as early as this week. 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
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. 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
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. mark for My Articles similar articles
The Motley Fool
August 12, 2008
Brian Lawler
The FDA Stands Up Cardiome What does the approvable letter mean for Cardiome and other drug developers? 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
The Motley Fool
August 17, 2007
Brian Orelli
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. mark for My Articles similar articles
Chemistry World
June 22, 2011
Sarah Houlton
US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe. mark for My Articles similar articles
Food Engineering
June 4, 2007
Congress to beef up inspection activities With one food recall after another making headlines, Congress appears intent on beefing up federal government food inspection activities. mark for My Articles similar articles
IndustryWeek
October 19, 2011
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? mark for My Articles similar articles
The Motley Fool
December 22, 2003
Alyce Lomax
Losing Faith in Inspire Delay for its dry-eye treatment leaves investors uninspired. mark for My Articles similar articles
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 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
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
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
The Motley Fool
August 23, 2010
Brian Orelli
No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week. mark for My Articles similar articles
The Motley Fool
May 30, 2008
Brian Orelli
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. 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
The Motley Fool
November 3, 2009
Brian Orelli
A Little Distracted, Are You, Merck? The FDA rejects its latest application. 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
April 17, 2007
Brian Lawler
Neurochem Must Wait The FDA delays a regulatory decision on Neurochem's lead compound. Investors, take note. mark for My Articles similar articles
The Motley Fool
September 16, 2008
Brian Lawler
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. mark for My Articles similar articles
The Motley Fool
October 5, 2011
Brian Orelli
1 Sure Sign of an FDA Approval Transcept Pharmaceuticals shoots up 34% after announcing that the FDA had classified its resubmission as a class 1 response. mark for My Articles similar articles
Managed Care
June 2002
Oncologists: FDA needs to speed up approval of cancer-fighting drugs A Competitive Enterprise Institute survey of cancer specialists found that almost 8 of 10 oncologists think the FDA's approval process has "hurt their ability, at least once in their medical careers, to treat patients with the best possible care." mark for My Articles similar articles
The Motley Fool
October 18, 2006
Brian Lawler
Another Hard Pill to Swallow A former FDA chief will take the fall for not disclosing holdings, but the pharmaceuticals industry needs more than that. mark for My Articles similar articles
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. mark for My Articles similar articles
Chemistry World
January 21, 2010
Rebecca Renner
FDA shifts on BPA safety The US Food and Drug Administration has revised its position on the possible developmental health risks from bisphenol A, the controversial and widely used ingredient in hard plastic bottles and food packaging that it declared safe in 2008. mark for My Articles similar articles
Food Engineering
January 6, 2008
Regulatory Watch Push for larger FDA food safety budget... Study urged on food from cloned animal... mark for My Articles similar articles
The Motley Fool
February 16, 2010
Brian Orelli
For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward. mark for My Articles similar articles
The Motley Fool
January 17, 2007
Brian Lawler
Dendreon in the Fast Lane The FDA speeds up review of Dendreon's leading drug candidate. Investors, take note. mark for My Articles similar articles
The Motley Fool
May 20, 2010
Brian Orelli
FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down. mark for My Articles similar articles
The Motley Fool
June 12, 2007
Brian Lawler
Adolor Is Still Swinging The drugmaker bumps into the FDA as it pushes to do more testing of Entereg. mark for My Articles similar articles