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Pharmaceutical Executive November 1, 2011 Roger L. Williams	Spotlight on OTCs With OTCs challenging traditional approaches to quality, new opportunities are arising to support industry innovation and advance public health.
Chemistry World October 7, 2013 Andrew Williams	California takes on chemicals in consumer goods California has just introduced a new law to reduce the use of hazardous substances in products and industrial processes in the state.
Pharmaceutical Executive October 1, 2006 Jill Wechsler	Washington Report: After Plan B: Out of the Quagmire, into the Data The morning-after pill goes OTC, with some special requirements. But is FDA's drug information system up to the task of tracking how it is used?
Pharmaceutical Executive April 1, 2007 McCook & Daniels	Making the Switch More companies are using Rx-to-OTC switches to extend a brand's life cycle. Prilosec did it. Here, experts dish on how you can do it too.
Pharmaceutical Executive July 1, 2014 Jill Wechsler	Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace.
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 February 2011 David Joy	7 Things You Should Know About The New Food Safety Law Considered a win for consumers, the new law will have varying effects on food & beverage processors.
Chemistry World April 1, 2010 Hepeng Jia	China Updates Chemical Legislation After a seven-year delay, China has introduced an updated version of its chemical registration and evaluation rules, bringing the country in line with chemical regulation efforts in other parts of the world.
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.
Reason September 2005 Kerry Howley	Locking Up Life-Saving Drugs U.S. prescription laws make us sicker and poorer because the system that puts drugs over the counter is driven by profits and patents.
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?
Managed Care November 2004 Martin Sipkoff	OTC Status for Low-Dose Lovastatin Would Have Widespread Implications The FDA stands poised to approve OTC low-dose statins, following a similar change in United Kingdom.
Pharmaceutical Executive March 1, 2006 Jill Wechsler	Washington Report: Labels and Liability New FDA guidance aims at better communication of risks. But it creates some, too.
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.
Reason April 2004 Todd Seavey	Regulation for Dummies A book about the FDA.
Food Engineering May 1, 2005 John Blanchard	Beyond the Bioterrorism Act What you need to know about the final rule and additional initiatives to meet the intent of the Bioterrorism Act -- particularly Section 306, which relates directly to those who manufacture, process, pack, transport, distribute, receive, hold, or import food products.
Pharmaceutical Executive March 1, 2007 Jill Wechsler	Washington Report: Safety First FDA seeks to regain public trust by making drug-safety information more transparent - and to head off more stringent legislation in the process.
Chemistry World May 14, 2015 Rebecca Trager	California demands warning labels for BPA The US state of California has added bisphenol A to its Proposition 65 list of chemicals linked to health concerns, despite opposition from the chemical industry.
Pharmaceutical Executive March 1, 2006 Sarah Houlton	Global Report: Chemicals Legislation in Europe Chemicals legislation in Europe may affect pharma's relationship with suppliers.
Chemistry World April 16, 2010 Rebecca Trager	Congress proposes toxic chemical regulation reforms The US Congress launched a much anticipated effort to update the nation's 34-year-old law governing new and already existing toxic chemicals yesterday.
Pharmaceutical Executive July 3, 2007 Louis A. Morris	Culture Shock The withdrawal of Vioxx signaled a sea change. Welcome to the Culture of Drug Safety. The FDA is making changes in the way it reviews drug safety. Post-marketing staff has been enlarged 25%, and new, tougher laws are on the way.
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.
Chemistry World May 14, 2015 Rebecca Trager	FDA accused of violating drug company's freedom of speech The US Food and Drug Administration is under pressure to reconsider its policy prohibiting pharmaceutical companies from promoting 'off-label' uses of their products.
Pharmaceutical Executive May 1, 2005 Jill Wechsler	Washington Report: The Pendulum Swings FDA cracks down on safety. Haven't we been here before? Perhaps in the end, the public will have a better understanding of the dangers associated with all pharmaceuticals and how virtually impossible it is to guarantee a risk-free medical treatment.
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?
Chemistry World December 19, 2011 Rebecca Trager	US agencies collaborate to test 10,000 chemicals A high-speed robotic screening system jointly initiated by three key US health agencies began testing more than 10,000 chemical compounds for potential toxicity on 7 December.
Chemistry World March 30, 2009 Rebecca Trager	EPA announces new chemical toxicity plan New regulations mean the agency will now rely less on animal testing to assess toxicity and risk, focusing instead on using advanced tools from fields like genomics, molecular biology and computational sciences.
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?
Food Processing June 2013 Butte & Whitesell	The FDA Must Define 'Natural' Soon 50 different state laws on labeling natural and genetically engineered foods would harm us all.
Pharmaceutical Executive May 1, 2011 John F. Brenner	Expanded Liability for Generic, Brand Manufacturers Ahead? To what extent are generics companies obligated by law to request labeling changes with FDA?
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.
Food Processing February 2012 Eric Lindstrom	The FDA's Food Safety Outlook for 2012 The FDA will be consumed with implementing the Food Safety Modernization Act, with July as a particularly important month.
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 November 15, 2012 Rebecca Trager	Obama re-election worries chemical industry Groups such as the Society of Chemical Manufacturers and Affiliates and the National Association of Chemical Distributors are worried that the president's second term will feature more forceful environmental regulation.
Chemistry World October 1, 2008 Rebecca Trager	US to Overhaul Industrial Chemicals Inventory A plan by the US Environmental Protection Agency to overhaul its inventory of industrial chemicals could lead to a lot more paperwork for chemical firms, industry officials have warned.
Pharmaceutical Executive June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
Chemistry World June 26, 2015 Rebecca Trager	Chemical reform bill advances in US Congress The US House of Representatives has approved a bipartisan bill to revamp the nearly 40-year-old law that governs America's chemicals policy, known as the Toxic Substances Control Act.
Reason Aug/Sep 2009 Jacob Sullum	Cigarette Gag: Smokes and speech In April a bill was passed that includes a provision barring manufacturers from making any statement directed to consumers through the media that would reasonably be expected to result in consumers believing that the product is regulated and endorsed by the FDA
Food Processing April 2007 Leslie Krasny	Wellness Foods' Regulatory Issues: It's a Natural The FDA has not been active in challenging "natural" claims for foods, although "warning" letters have been sent to manufacturers, particularly for the use of color additives in products bearing "natural" claims.
Searcher June 2012 Stephanie C. Ardito	The Medical Digital: How Safe Are the Prescription Drugs we Take? Monitoring Adverse Events and Recalls For general information about prescription and clinical trial drugs, the following websites have been around for a while and have excellent reputations.
Food Processing January 2007 David Joy	FDA considers functional foods There is no formal regulatory definition associated with the term "functional foods," but the FDA is soliciting information and comments on whether or not these foods should be regulated more strictly.
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, 2014 dos Santos & Leskin	Social Media and the In-House Counsel Social media poses a regulatory and litigation maze that must be carefully navigated by pharmaceutical companies.
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 30, 2007 Louis A. Morris	Safety Net The new Culture of Drug Safety means embracing the benefit of no doubt about a product's pluses and its minuses. Pharma must learn how patients and prescribers weigh risks and how to spread the word about the advantages.
Pharmaceutical Executive September 1, 2008 Jill Wechsler	Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches.
Salon.com October 31, 2002 Arianna Huffington	Drugging our children the legal way America's legal drug pushers are free to offer kids their potent concoctions without having to prove they're safe or effective.
Food Processing August 2013 Eric Lindstrom	FDA Paints Itself Into a Corner with FSMA A federal judge orders the agency to issue overdue food safety rules by November ... which looks unrealistic.
Chemistry World July 26, 2012 Andrew Turley	New US chemical rules edge nearer A political committee in the US has voted in favor of plans to change the way chemicals are regulated by shifting the burden of proving safety to manufacturers.
Food Processing July 2005 David Joy	Regulatory Issues: What's in a name? The Food and Drug Administration and the U.S. Dept. of Agriculture recently published a joint proposal to amend their regulations dealing with food "standards of identity."