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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 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
The Motley Fool
May 27, 2009
Brian Orelli
Meet the People Who'll Rule Your Investment Life If you're a drug company investor, that is. The new commissioner and principal deputy commissioner of the Food and Drug Administration introduced themselves and give investors a first look at how they plan to run the agency. mark for My Articles similar articles
IndustryWeek
October 19, 2011
FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies? 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
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. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2011
Jill Wechsler
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes mark for My Articles similar articles
Chemistry World
January 21, 2010
Rebecca Renner
FDA shifts on BPA safety The US Food and Drug Administration has revised its position on the possible developmental health risks from bisphenol A, the controversial and widely used ingredient in hard plastic bottles and food packaging that it declared safe in 2008. mark for My Articles similar articles
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. 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
September 1, 2010
The Testing of the Tests FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development. 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
HBS Working Knowledge
September 24, 2007
Sean Silverthorne
The FDA: What Will the Next 100 Years Bring? The challenge for FDA leaders is to maintain morale and focus, and to back up decisions with solid data on benefits and risks to different consumer populations. 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, 2011
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. mark for My Articles similar articles
The Motley Fool
March 16, 2009
Brian Orelli
Will the New FDA Chief Make Your Investments Healthy? President Obama's choice of Margaret Hamburg as head of the FDA seems to signify that the president is interested in the agency turning its focus toward protecting American's health. 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
October 1, 2011
Ansis Helmanis
Lessons from the FDA Front Line Is the research-based industry less productive today than 30 years ago? To former Commissioner Jane Henney, the answer is straightforward. mark for My Articles similar articles
Bio-IT World
April 2007
John Russell
Whatever Happened to the Critical Path? Science progresses at its own rate and medical science is necessarily more cautious than other branches. But it feels like the lack of money and mindshare are turning the FDA's Critical Path Initiative into just another umbrella project. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
March 24, 2009
Brian Orelli
Taking the F Out of FDA President Barack Obama's nomination for deputy commissioner of the Food and Drug Administration has gotten people talking about the possibility of splitting the food safety portion away from the drug portion of the agency. mark for My Articles similar articles
Chemistry World
February 8, 2012
Rebecca Trager
Obama urged to cut FDA ties with Monsanto The petition specifically mentions Michael Taylor as a former vice president and lobbyist with the firm, and suggests that he should be removed from his position as the FDA's deputy commissioner for foods. mark for My Articles similar articles
The Motley Fool
February 22, 2011
Brian Orelli
A Billion-Dollar Market to Open "Very Soon" Biosimilar drugs are finally coming to the U.S. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
July 1, 2009
Jill Wechsler
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. mark for My Articles similar articles
Chemistry World
February 3, 2012
Rebecca Trager
Whistleblowers accuse FDA of spying, persecution The US Food and Drug Administration is being sued by its own scientists and doctors who allege they were spied on and persecuted by the agency for expressing safety concerns about the approval of medical devices. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
BusinessWeek
May 21, 2007
John Carey
A Shot At Making Drugs Safer Congress could revamp the cozy ties between drugmakers and the FDA. Will it? mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
October 1, 2011
Jill Wechsler
Pharma's Unlikely Best Friend Sidney Wolfe has been a thorn in the side of pharma and the FDA for almost 40 years, but is also a widely respected and highly vocal critic of industry practices and products, and a visible influence on regulatory policies. mark for My Articles similar articles
Chemistry World
February 17, 2010
Sarah Houlton
Europe's new research commissioner sworn in Career politician Maire Geoghegan-Quinn trained as a teacher, and will now be responsible for driving the EU's science agenda. mark for My Articles similar articles
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. mark for My Articles similar articles
Pharmaceutical Executive
December 1, 2010
Jill Wechsler
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2012
Jill Wechsler
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation. mark for My Articles similar articles
Food Engineering
June 4, 2007
Congress to beef up inspection activities With one food recall after another making headlines, Congress appears intent on beefing up federal government food inspection activities. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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
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
The Motley Fool
May 26, 2009
Colleen Paulson
What's Your MO, Altria? Altria is actively supporting FDA regulation of cigarettes. Read on to see why. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2012
Clark Herman
Prix Galien: Night at the Museum Representatives of Big Pharma and trade association leaders at the New York Museum of Natural History had one purpose in mind: to recognize the latest innovations in new drugs and medical devices. mark for My Articles similar articles
Food Engineering
December 1, 2008
Regulatory Watch: Will food safety be a priority for Obama? A strong FDA Commissioner is seen as a first step toward restoring integrity to the food inspection process. mark for My Articles similar articles
Chemistry World
March 1, 2010
Rebecca Trager
US launches new regulatory science program Two major US government agencies have partnered to create a new regulatory science program to ensure better integration between cutting edge science and regulatory processes in assessing new medical products or compounds flowing from biomedical research. mark for My Articles similar articles
Chemistry World
September 1, 2015
Rebecca Trager
FDA takes action to remove biosimilars roadblock In a move expected to facilitate the entry of biosimilar drugs into the US market, the US Food and Drug Administration has proposed a system for naming such copycat versions of biological drugs. 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
Bio-IT World
September 11, 2003
John Russell
This Goose Is Better Uncooked From 'Poison Squad' to pharma watchdog, the ever-changing and controversial role of the FDA makes for fascinating history. mark for My Articles similar articles