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Pharmaceutical Executive September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches. |
Chemistry World May 23, 2012 Andy Extance |
Drug watchdogs mark out global territory The US Food and Drug Administration has published plans to ensure that American citizens continue to enjoy access to safe drugs, even as the regulatory pressures of globalization grow. |
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 November 1, 2008 Patrick Clinton |
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? |
Pharmaceutical Executive July 1, 2013 Jill Wechsler |
Seeking Supply Chain Security FDA wants pharma leaders to do more to ensure drug quality at home and abroad. |
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 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. |
Food Processing February 2008 |
Ingredients from Where? A flattening world, consumer price resistance and overtaxed regulators require new approaches to ensure the safety of imported food ingredients. |
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. |
Chemistry World September 18, 2008 James Mitchell Crow |
Ranbaxy hit by US drug ban The US Food and Drug Administration (FDA) has banned the import of more than 30 drugs made by Ranbaxy, India's largest drugmaker. |
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. |
The Motley Fool February 21, 2008 Brian Lawler |
A Bit of Irony From the FDA The agency has a mixed message on drug importation, as evidenced in the recent possible contamination of China-produced Heparin. |
Chemistry World July 16, 2015 Rebecca Trager |
US import ban imposed on Indian pharma firm The US Food and Drug Administration has prohibited India's Emcure Pharmaceuticals from importing drugs manufactured at its Maharashtra-based facility into the US owing to concerns over its manufacturing practices. |
Chemistry World November 21, 2014 Rebecca Trager |
Ranbaxy sues over withdrawn US approvals Ranbaxy -- India's largest generics manufacturer -- has sued the US Food and Drug Administration after the agency withdrew tentative approval for the company to sell generic versions of two blockbuster drugs |
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. |
Prepared Foods January 2008 Mark S. Hostetler |
Regulations: That's the Plan The much-anticipated Food Protection Plan from the FDA integrates two plans that address safety for domestic and imported foods. |
Food Processing October 2008 Diane Toops |
A Conversation with Food Safety Czar David W.K. Acheson A exclusive conversation with `food safety czar' David W.K. Acheson, FDA's Associate Commissioner for Foods. |
Pharmaceutical Executive December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes |
Chemistry World June 10, 2013 Phillip Broadwith |
Sandoz manufacturing woes continue Sandoz, the generic drugs arm of Swiss firm Novartis, has had an official warning from the US Food and Drug Administration over failings at one of its manufacturing plants. |
Pharmaceutical Executive January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
The Motley Fool July 30, 2010 Brian Orelli |
A Faster Pathway to Drug Approvals A thinktank called the Pacific Research Institute has proposed letting drugs approved by the European Medicines Authority onto the market in the U.S. before the Food and Drug Administration has approved the drugs. |
Chemistry World October 17, 2014 Dinsa Sachan |
Indian manufacturers hit back over quality claims The Indian pharmaceutical industry has asked its government to sue authors of a study published by the US National Bureau of Economic Research in early September. |
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 December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
Pharmaceutical Executive September 1, 2006 Jill Wechsler |
Pharm Exec Q&A: A Soft Spot for Whistleblowers FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive interview, he explains where the agency goes wrong and what he would do to fix it. |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
The Motley Fool September 18, 2008 Brian Orelli |
Ranbaxy's Troubles Won't Help Competitors The FDA will block the importing of more than 30 drugs and ingredients until Ranbaxy's problems at two Indian manufacturing plants are resolved. |
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. |
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 Jill Wechsler |
Washington Report: Antivirals: Meeting a World of Need The international fight against AIDS requires drugs -- and policy. |
Chemistry World July 10, 2012 |
Interview: EMA head Guido Rasi His five-year appointment comes during a period of dramatic change for the pharma industry, which is struggling with patent expirations for many of its biggest selling drugs and a paucity of new drugs coming through the pipeline to take their place. |
Chemistry World October 23, 2013 Sarah Houlton |
Pharma manufacturing woes dog industry Many problems arise from quality control failures, according to Nicholson Price from Harvard Law School's Petrie-Flom center for health law policy, biotechnology and bioethics, this is not the only problem -- regulatory constraints can prevent process improvements being made. |
The Motley Fool September 16, 2008 Brian Lawler |
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. |
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? |
BusinessWeek December 13, 2004 John Carey |
How To Prevent Another Vioxx The tragedy should spur Congress and the FDA to improve the safety of new drugs. |
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 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. |
The Motley Fool December 3, 2010 Travis Hoium |
Orexigen Therapeutics Shares Plunged: What You Need to Know Shares of biopharmaceutical company Orexigen Therapeutics fell 10% today after a Food and Drug Administration announcement. |
Pharmaceutical Executive July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
The Motley Fool March 7, 2005 Brian Gorman |
Glaxo in Hot Water Glaxo's problems with the FDA could have been avoided. Investors can only hope that the FDA is in a forgiving mood. |
InternetNews December 6, 2005 Colin C. Haley |
Microsoft Plans 30 New R&D Centers Microsoft Chairman Bill Gates kicked off a four-day India trip by outlining a plan to build 30 new innovation centers around the world, including one in the tech-heavy Indian city of Bangalore. |
BusinessWeek May 3, 2004 John Carey |
Is Reimporting Drugs A Cheap Fix? Not Really Why reimporting drugs from Canada won't work in the long run |
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. |
Food Processing September 2010 Diane Toops |
Congress Scrambles to Pass Food Safety Legislation As Congress has argued over health care reform, financial reform, two wars, a mortgage crisis and unemployment, amending the U.S. food safety system was put on the back burner. |
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. |
Chemistry World September 24, 2010 Andrew Turley |
End of the road for Avandia? The European Medicines Agency has decided the troubled diabetes drug should be pulled from the market while the US Food and Drug Administration has said it will 'significantly restrict' its use. |
Pharmaceutical Executive April 1, 2012 Feam & Lagus |
Providing Access Now While regulatory frameworks and medical practices differ between countries, many patients still need early access to new drugs. Industry can 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. |
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. |