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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. mark for My Articles similar articles
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. 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
November 1, 2008
Patrick Clinton
Over There Is it the FDA's responsibility to be in charge of inspections at foreign pharmaceutical plants? mark for My Articles similar articles
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. 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
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
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. 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
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. 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
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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 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
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. mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
Pharmaceutical Executive
January 1, 2014
Jill Wechsler
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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? mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
Pharmaceutical Executive
November 1, 2011
Jill Wechsler
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. mark for My Articles similar articles
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. 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
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
October 1, 2005
Jill Wechsler
Washington Report: Antivirals: Meeting a World of Need The international fight against AIDS requires drugs -- and policy. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
The Motley Fool
September 16, 2008
Brian Lawler
Pfizer Puts Safety First Increased FDA scrutiny may motivate the pharmaceutical's new drug-safety site. 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
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. 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
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. mark for My Articles similar articles
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. 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
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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 mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. mark for My Articles similar articles
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. 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