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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.
Pharmaceutical Executive July 10, 2014 Ben Comer	FDA Spread Thinly Abroad Is FDA capable of sufficiently overseeing global drug imports?
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.
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.
Chemistry World October 23, 2009 Matt Wilkinson	What's in a pill? Buying cheap drugs over the internet is well known to be a risky business. But the sinister menace of the 'falsified' active pharmaceutical ingredient gets far less publicity.
Chemistry World June 21, 2010 Sarah Houlton	Recalling pharma Recent drug withdrawals and manufacturing failures have highlighted the importance of ensuring that the medicines patients take contain what it says on the label.
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.
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 April 1, 2012	Country Report: Ukraine Despite the severe blow to its economy, Ukraine has been recovering at a faster rate than its Western European counterparts. But what has such rapid development done for the country's healthcare?
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 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 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.
Chemistry World August 21, 2015 Sa njay Kumar	Indian pharma under increased regulatory scrutiny A Europe-wide ban on hundreds of generic pharmaceutical formulations tested by Indian contract research firm GVK Biosciences comes into force today.
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 August 1, 2013 William Looney	Breaching the Great Wall With a revision of China's basic drug approval law now underway, a multinational team of experts is proposing major changes to make the country a world class player in innovation.
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.
Pharmaceutical Executive December 1, 2010	The Sum of All His Parts: Career Reflections of Europe's Chief Drug Regulator The European Medicines Agency is a unique institution, pursuing a mandate shared with a complex web of national and regional groups, each able to place a distinctive imprint around the delicate task of certifying the safety and efficacy of new drugs.
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.
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, 2014 William Looney	Ireland's Celtic Tiger: Back on the Hunt Leaders from industry, government, and the CRO community examine Ireland's future as a magnet for life science investments, and what the nation must do to remain the leading exporter of finished pharmaceutical products.
Chemistry World December 19, 2013 Steven Ford	Cut price pills cost more than pennies We need to take a good look at supply diversity: we cannot allow the situation where suppliers are too big to fail. It's time to raise the bar across the pharmaceutical supply line from producer to patient.
Chemistry World February 2, 2015 Rebecca Trager	EU regulator calls for generic drug suspensions The European Medicines Agency) has accused an Indian contract research organization of systematic fraud, and has recommended suspending sales of hundreds of generic drug formulations in Europe.
Chemistry World January 27, 2014 Phillip Broadwith	US blocks imports from fourth Ranbaxy plant The US Food and Drug Administration has banned Indian drugmaker Ranbaxy from importing active pharmaceutical ingredients produced at its plant at Toansa, India, into the US.
Pharmaceutical Executive November 1, 2012 Gorsen et al.	OTC Crunch Time in California Over-the-counter products face a new wave of regulation.
Chemistry World July 13, 2007 Hepeng Jia	Chinese Legislation to Increase Drug Safety A long-awaited amendment to China's drug registration system is expected to discipline the country's medical sector and boost the pharmaceutical industry.
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.
Chemistry World June 22, 2011 Sarah Houlton	US Approves Cancer Drugs Twice as Fast as Europe Cancer drugs are, on average, approved nearly twice as fast in the US than they are in Europe.
Pharmaceutical Executive December 1, 2005 Jill Wechsler	Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning.
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 November 1, 2011 Jill Wechsler	The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices.
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.
Pharmaceutical Executive October 1, 2011	The Essential--and Effective--Bureaucrat Fernand Sauer, First Director General, European Medicines Agency, has witnessed the progressive sterilization of innovative research due to a trend toward ever-larger industry concentration.
Chemistry World April 9, 2014 Andy Extance	Sun set on Ranbaxy rescue India's Sun Pharma will acquire its compatriot Ranbaxy in a $3.2 billion all-share deal that will create the world's fourth largest generic drugs producer.
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?
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
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 July 1, 2009 Jill Wechsler	Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon.
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 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.
The Motley Fool February 23, 2004 Brian Gorman	Abbott Cleans Up Its Act Abbott closes the books on its problems with the FDA and clears the way to a spinoff. Abbott finally passed FDA muster with its Illinois diagnostics plant. Its multi-year problem highlights the importance of investors monitoring manufacturing while watching a pharmaceutical company's pipeline. And with its FDA compliance issues behind it, Abbott can look forward to spinning off its Hospital Products Division.
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 February 1, 2014 Longacre et al.	Social Media: Have We Reached The Tipping Point? For pharma marketers, the good news is recent advances in social media monitoring make it possible to listen to or engage with patients on social media websites. This month FDA released its draft guidance on the use of "Interactive Promotional Media."
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 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.
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.
Pharmaceutical Executive January 1, 2014 Jill Wechsler	Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing
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 17, 2010 Andrew Turley	Free trade could throttle generics from India International agreements on intellectual property threaten the flow of generic HIV drugs from India to developing countries, according to a new report.
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
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.