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Bio-IT World April 16, 2004	Best of the Best, Sir The FDA wants to change its ways and share its accumulated wisdom as part of a focused attack on costly, unpredictable product development.
Bio-IT World April 2006 John Russell	Lobbying for Critical Path Funding The FDA's Critical Path Initiative is an important program in need of cold hard cash and dedicated FDA personnel.
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.
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 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 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?
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.
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.
Pharmaceutical Executive May 1, 2006 Jill Wechsler	Washington Report: Opportunity Knocks FDA has finally released its long-awaited list of research opportunities for the Critical Path initiative. Now comes the hard part, as companies learn how to collaborate on projects that will benefit pharma as a whole.
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 December 1, 2010 Ansis Helmanis	A New Twist in the Cost Curve The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Is industry prepared to adapt or challenge?
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
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 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.
The Motley Fool March 31, 2008 Brian Lawler	FDA Commish Joins Blogosphere Andrew von Eschenbach, the FDA's chief, starts a weekly blog.
Food Processing January 2005 David Joy	Regulatory Issues: The FDA agenda for 2005 As in the past, the FDA has a full agenda of food regulatory matters in 2005. So it's not good that the FDA's scientists are demoralized and the agency stands accused of being too friendly with a regulated industry.
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 December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
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 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.
Pharmaceutical Executive November 1, 2008 Jill Wechsler	Resolving Conflicting Interests The Physician Payment Sunshine Act would require pharmaceutical and medical device companies to disclose payments of more than $500 to doctors.
Bio-IT World September 2005 John Russell	Labor Pains and Gains Labor Day is the starting gun for the bio-science industry's race through the next year. Here are some up-and-coming items to watch: Transparency... Systems Biology... Crawford and McClellan...
Pharmaceutical Executive May 1, 2007 Weiner & Hovde	Critical Mass for Critical Path? Everyone agrees that it's the road to pharma's future, but no one's rushing to take it. Yet with growing FDA advocacy and new advances in biomarkers and drug-disease modeling, the rewards of collaboration now look greater than the risks.
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.
Chemistry World May 21, 2009 Rebecca Trager	FDA gets new chief The US Food and Drug Administration's (FDA) new commissioner, Margaret Hamburg, will be the second woman to ever lead FDA
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.
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.
Entrepreneur March 2005 Stephen Barlas	Just the facts The FDA doesn't want any more lies on dietary supplement labels... Is Sarbanes-Oxley a Class Act?... 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.
Bio-IT World August 13, 2003 John Rhodes	Beyond the Blockbuster Genomics and big hits are not mutually exclusive, writes Deloitte & Touche's life sciences expert.
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?
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.
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.
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.
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.
The Motley Fool November 17, 2010 Brian Orelli	52 Years Down, 1 Month to Go Lupus treatment Benlysta moves closer to approval.
Bio-IT World August 18, 2004 Anthony Strattner	Opportunity to Gain or Lose A keynote speaker at Best Practices ceremony asserts that drug-development science -- those activities that go beyond translational science and into product testing and commercialization -- has stagnated, causing a pipeline problem.
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 June 16, 2011 Brian Orelli	No Poke in the Eye Here What's the biggest sign that the Food and Drug Administration is all set to approve Regeneron Pharmaceuticals' Eylea? The briefing documents for the advisory committee contained a proposed version of the label.
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.
Bio-IT World September 2006 Kevin Davies	The $2 Billion Pill? Challenges and opportunities facing the drug industry were recurring themes in the quartet of keynote speeches at the 2006 Drug Discovery Technology conference.
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
Food Processing September 2007	Regulatory Issues: Navigating the health claim maze FDA's recent guidance focuses only on the process for evaluating evidence supporting a health claim on food labels.
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 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 October 1, 2012 Jill Wechsler	Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny.
The Motley Fool November 8, 2007 Charly Travers	BioMarin Tips Its Hand BioMarin Pharmaceutical awaits an FDA decision on its drug Kuvan for the treatment of phenylketonuria. The company's recent conference call implies approval is imminent.
Managed Care February 2008 Martin Sipkoff	FDA Approach to Generics May Be a Mixed Blessing A recently announced initiative is supposed to speed approval of generic drugs, but does it address some fundamental flaws in the approval process?
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
Bio-IT World Jul/Aug 2006 John Russell	Pharsight CRADA to Assist FDA with Modeling Initiative Pharsight will use FDA's feedback to further develop their server to meet drug-maker's analysis requirements, and further develop their visualization and collaboration tool to support FDA-sponsor interactions for the visualization and communication of model-based product profiles.