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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. |
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. |
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 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. |
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. |
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. |
BusinessWeek January 8, 2007 Arlene Weintraub |
Is Your Medicine The Real Deal? Accusations are flying that some pharmacies substitute inferior versions of drugs. |
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. |
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. |
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. |
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. |
The Motley Fool May 30, 2008 Brian Orelli |
No Love for Antibiotics From the FDA Wyeth gets an approvable letter for its antibiotic Tygacil. |
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. |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
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. |
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. |
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? |
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. |
BusinessWeek November 29, 2004 Carey & Barrett |
Lessons From The Vioxx Fiasco What drugmakers, the FDA, doctors, and patients need to do. |
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 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. |
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. |
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. |
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. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
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? |
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 April 29, 2008 Brian Orelli |
Will These Drugs Get FDA Approval? Discovery Laboratories and Adolor are waiting FDA decisions on their drugs next month. |
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 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. |
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 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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
AskMen.com October 30, 2015 Asandra & Palubicki |
Are Erectile Dysfunction Supplements Dangerous? Here's why erectile dysfunction supplements can be extremely dangerous. |
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. |
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." |
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. |
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. |
The Motley Fool December 27, 2004 W.D. Crotty |
Drug Safety: Investors Beware Will AstraZeneca become the latest casualty in the drug safety debate? |
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. |
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. |
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. |
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? |
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 |