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Pharmaceutical Executive
December 1, 2005
Grant Winter
Inside DDMAC: A Conversation with Thomas Abrams Despite heightened scrutiny from industry advocates and the beginnings of self-imposed regulation, pharma companies' violations of DTC regulations have been getting worse, says the director of FDA's Division of Drug Marketing, Advertising, and Communications. mark for My Articles similar articles
Pharmaceutical Executive
June 1, 2014
dos Santos & Leskin
Social Media and the In-House Counsel Social media poses a regulatory and litigation maze that must be carefully navigated by pharmaceutical companies. mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2012
Jennifer Ringler
Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines. mark for My Articles similar articles
BusinessWeek
January 8, 2007
Arlene Weintraub
Is Your Medicine The Real Deal? Accusations are flying that some pharmacies substitute inferior versions of drugs. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
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
Pharmaceutical Executive
June 1, 2009
Jill Wechsler
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. mark for My Articles similar articles
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. mark for My Articles similar articles
Managed Care
February 2007
MargaretAnn Cross
How Much Trouble Does Health Care Marketing Cause? Whether for drugs, imaging, surgery, or emergency services, direct-to-consumer advertising sparks lively debate. mark for My Articles similar articles
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? mark for My Articles similar articles
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. mark for My Articles similar articles
BusinessWeek
November 29, 2004
Carey & Barrett
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. 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
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
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
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
Bio-IT World
April 15, 2003
Janet Woodcock
FDA Director Explains the Changes The head of the Center for Drug Evaluation and Research discusses why the FDA is now kinder and gentler about Part 11 compliance. 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
Pharmaceutical Executive
November 1, 2008
Patrick Clinton
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? 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
April 29, 2008
Brian Orelli
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month. 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
April 10, 2008
Brian Lawler
Glaxo Angers the FDA GlaxoSmithKline announces that the FDA has sent it a warning letter regarding its failure to meet certain post-marketing requirements for Avandia. 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
Pharmaceutical Executive
March 1, 2012
Jill Wechsler
When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications. 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
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
Reason
May 2005
Ronald Bailey
Aborting Plan B Barr Pharmaceuticals wants to offer its emergency contraceptive levonorgestrel, marketed as Plan B, over the counter rather than by prescription. The FDA delayed an anticipated decision on the issue indefinitely, adding another chapter to a long and heavily politicized debate. mark for My Articles similar articles
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. mark for My Articles similar articles
Chemistry World
May 14, 2015
Rebecca Trager
FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
AskMen.com
October 30, 2015
Asandra & Palubicki
Are Erectile Dysfunction Supplements Dangerous? Here's why erectile dysfunction supplements can be extremely dangerous. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
February 1, 2014
Longacre et al.
Social Media: Have We Reached The Tipping Point? For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites. This month FDA released its draft guidance on the use of "Interactive Promotional Media." 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
The Motley Fool
May 11, 2006
Brian Lawler
Encysive Evasive About Thelin The pharmaceutical stays tight-lipped about FDA approval of its new drug. Investors should keep an eye on Encysive's cash-burn rate in the coming months. mark for My Articles similar articles
The Motley Fool
December 27, 2004
W.D. Crotty
Drug Safety: Investors Beware Will AstraZeneca become the latest casualty in the drug safety debate? mark for My Articles similar articles
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. mark for My Articles similar articles
Chemistry World
February 14, 2012
Rebecca Trager
FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones. mark for My Articles similar articles
Salon.com
October 31, 2002
Arianna Huffington
Drugging our children the legal way America's legal drug pushers are free to offer kids their potent concoctions without having to prove they're safe or effective. 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
Chemistry World
November 21, 2014
Rebecca Trager
Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs mark for My Articles similar articles