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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 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 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 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 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.
Pharmaceutical Executive June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
Pharmaceutical Executive July 30, 2007	Direct to Consumer: Creativity Through Understanding Creative consumer campaigns begin with a clear understanding of pharma rules and regulations.
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.
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.
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.
Pharmaceutical Executive January 1, 2011 Jill Wechsler	Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead.
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.
Pharmaceutical Executive May 1, 2005 Jill Wechsler	Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
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.
Pharmaceutical Executive September 1, 2010	To Brand or Not to Brand? The effectiveness of direct-to-consumer prescription advertising hinges on a consumer's thirst for information. A new study intimates the less info consumers are given up front, the more they seem willing to learn.
CIO March 15, 2006 Allan Holmes	Rx for Risk As it revamps its workflow processes, the FDA is relying on technology to reduce the risk that unsafe substances will get into the market.
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.
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."
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
Pharmaceutical Executive April 1, 2006 Diane West	Media Spend Trends: Change the Channel Drug marketers still spend lots of money. But they aim at PhRMA loopholes.
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 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 December 31, 2007 Brian Lawler	The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency.
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
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.
The Motley Fool April 11, 2008 Brian Lawler	Amgen's Unsurprising Delay The FDA extends its review of an Amgen drug candidate.
Pharmaceutical Executive May 1, 2009	Ad(Ventures) in Pharmaland Despite the downside in ad spend, an upside remains in the digital space that's wide open for exploration.
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.
American Family Physician December 1, 2000 William M. Rados	Online Information for Health Care Professionals The home page of the U.S. Food and Drug Administration has undergone a major revision. The agency's Web site, which includes more than 100,000 documents, is now easier to search and covers the full scope of the FDA's activities...
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?
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 September 1, 2011 Jill Wechsler	Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.
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.
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.
Pharmaceutical Executive January 1, 2006 Jill Wechsler	Washington Report: PDUFA Blues The Prescription Drug User Fee Act is up for reauthorization. Let the games begin.
The Motley Fool November 16, 2007 Brian Lawler	Scrutinizing FDA Drug Approvals Comparing the FDA's approval rate of new drugs by calendar year illustrates that the pace of approvals certainly has slowed since the 2004 recall of Merck's anti-inflammatory compound Vioxx.
Pharmaceutical Executive January 1, 2013 Jill Wechsler	Transformation to Characterize 2013 FDA policies will reshape drug development, while pressure to cut healthcare spending may alter drug coverage and pricing.
Pharmaceutical Executive July 3, 2007	Direct to Consumer: The Secret of My Success Pharmaceutical industry experts sound off on the methods behind an award-winning ad and how the next great direct-to-consumer campaign will come about.
The Motley Fool December 5, 2007 Brian Lawler	The FDA Says It Needs a Pep Pill Drugmakers offering new treatments might be discouraged by the FDA's latest report, in which the agency makes its case for additional funding from Congress.
The Motley Fool October 19, 2010 Brian Orelli	Why the FDA Won't Approve Lorcaserin and Qnexa (Yet) Obesity drugs get their day in front of the agency.
The Motley Fool November 14, 2007 Brian Lawler	Is the FDA Still Approving New Drugs? Lately the FDA seems more reluctant to approve new drugs than it once was. Let's take a look at the actual numbers from the past eight years.
Pharmaceutical Executive May 1, 2005 Diane West	Media Spend Trends: Changing Lanes You've got their attention---now what? Pharma marketing analysts predict a spending shift from branded direct-to-consumer efforts to more disease awareness and corporate reputation promotions.
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?
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.
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.
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.
Pharmaceutical Executive January 1, 2006 Clinton & Wechsler	What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay?
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.
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.