Similar Articles |
|
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 June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
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. |
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 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 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 December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes |
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. |
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 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 September 1, 2010 |
The Testing of the Tests FDA seeks to regulate genetic tests more actively, while encouraging diagnostic development. |
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. |
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. |
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, 2011 |
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. |
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. |
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 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. |
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. |
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 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. |
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. |
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. |
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 July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
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. |
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. |
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. |
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 September 1, 2011 Jill Wechsler |
Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight. |
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? |
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. |
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. |
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. |
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 December 1, 2010 Jill Wechsler |
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research |
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. |
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. |
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. |
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 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 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. |
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 May 26, 2009 Colleen Paulson |
What's Your MO, Altria? Altria is actively supporting FDA regulation of cigarettes. Read on to see why. |
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. |
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. |
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. |
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. |
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. |
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. |