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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 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.
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 This month FDA released its draft guidance on the use of "Interactive Promotional Media."
Fast Company Neal Ungerleider	Why Kim Kardashian's Instagram Post Was In Violation Of FDA Rules Her paid endorsement did not make mandatory statements about Diclegis' side effects and comply with the same rules that require spoken disclaimers at the close of television commercials for prescription drugs.
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.
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.
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.
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.
Pharmaceutical Executive July 1, 2011	How to Prevent a Facebook Faux Pas Here are a few 'Like' and 'Dislike' practices that companies should consider, prior to Facebook's great enabling.
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.
Pharmaceutical Executive June 1, 2009 Michael Maher	Learning to Relate A multi-phase implementation strategy can debunk the myth that social media won't work for pharma.
Pharmaceutical Executive January 1, 2013	Product Liability Claims and Comment K Courts across the country are making it easier to prove that a drug is unsafe, warning label notwithstanding.
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.
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.
The Motley Fool December 22, 2006 Stephen Albainy-Jenei	Is Off-Label Off-Base? Off-label prescriptions for uses lacking scientific support account for billions in drug revenue for Eli Lilly. If the FDA takes an aggressive stance on off-label-use marketing, it could significantly shrink drug sales for companies whose revenues are derived largely from such off-label use.
Pharmaceutical Executive February 1, 2013 Julin et al.	Fortuity and the First Amendment Caronia decision shows the staying power of Sorrell v. IMS Health. Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs.
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.
Pharmaceutical Executive October 1, 2005 Andy Bender	Orchestrating Compliance Product managers at pharmaceuticals are not always happy to see their compliance officers. That may be changing.
Pharmaceutical Executive September 1, 2011	Pharma and Social Media: Ready to Make Nice? The time is right for industry to overcome its social media phobia once and for all.
Pharmaceutical Executive July 30, 2007 Louis A. Morris	Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages.
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.
Managed Care August 2006 Martin Sipkoff	Off-Label Use Often Presents Conundrum for Health Plans Insurers recognize the clinical importance of off-label prescribing, but criteria are needed to avoid over-utilization.
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.
Chemistry World November 2, 2011 Rebecca Trager	Escalating Drug Dearth Spooks White House Manufacturing problems are the principal reason for the rapid growth in drug shortages.
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 January 1, 2012	Compliance: Getting Those Ducks in a Row Pharma must coordinate the efforts of medical, legal, HR, global partners and many other players in the regulatory compliance space to keep itself afloat in choppy seas.
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 March 1, 2012 B. Brett Heavner	Judging a Pill by its Cover Pharmaceutical trade dress is an effective marketing tool that helps boost product recognition for consumers. It's worth protecting.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.
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, 2012 Jill Wechsler	Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives.
Pharmaceutical Executive June 1, 2012 Jill Wechsler	Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.
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.
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 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.
Pharmaceutical Executive January 1, 2007 Jill Wechsler	Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007.
Pharmaceutical Executive October 1, 2005 Patrick Clinton	From the Editor: No Substitutes Don't use surrogate measures in clinical drug trials, says a major industry critic. OK, but don't the critics base a lot of their points on surrogate measures, too?
Pharmaceutical Executive February 1, 2006 Jill Wechsler	Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development.
Pharmaceutical Executive May 1, 2007 Diane West	Spend Trends 2007: Hang 10 Direct-to-Consumer Advertising Hits Its First Decade: Dr. Dot-Com... Digital Detailing... etc.
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.
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 November 1, 2012 Gorsen et al.	OTC Crunch Time in California Over-the-counter products face a new wave of regulation.
Pharmaceutical Executive July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
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 June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
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.
CRM February 2, 2003 David Myron	Vertical Focus: Pharmaceuticals Pharmaceutical companies are prolonging the good health of their customers -- and the CRM industry. Largely influenced by retiring Baby Boomers, lack of FDA-approved drugs in the pipeline, and direct selling campaigns, the industry is becoming more customer-focused.
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.
Reason April 2008 Ronald Bailey	Medical Speech As a 1997 law expires, the FDA is mulling a plan allowing companies to disseminate unabridged reprints of "truthful and non-misleading" medical journal articles describing "off-label" uses of approved medications to physicians.
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?