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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.  |
Food Processing January 2013 Eric Lindstrom |
Food Safety Regulatory Outlook for 2013 Similar to 2012, the FDA will continue to evolve and enact the Food Safety Modernization Act.  |
Food Processing March 2013 Eric Lindstrom |
Do you know your HACCP from your HARPC? FDA's FSMA ruling requires food processors to create risk-based preventive control plans.  |
Food Processing October 2012 |
FDA Assesses its FSMA Progress The Deputy Commissioner for Foods, Michael Taylor, outlines his accomplishments and his to-do list.  |
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.  |
Food Processing June 2011 Leslie Krasny |
Regulatory Compliance: Imports Now Under Greater Scrutiny The new Food Safety Modernization Act and PREDICT mean tougher qualifications.  |
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."  |
Food Processing July 2013 |
Using Technology to Aid the FSMA Implementation Leavitt Partners' David Acheson attests managing the requirements of FSMA will require leveraging technology.  |
Food Processing August 2012 David Acheson |
Focus on Food Safety: China's New Food Safety Initiatives Five-year plan lacks specific regulations but shows signs of progress.  |
Food Processing January 2012 Dave Fusaro |
Focus on Food Safety: A Busy Year for Food Safety The vigilance over keeping bugs out of the food supply never lets up, but there are a couple of things on the horizon that will make 2012 a watershed year.  |
Salon.com November 7, 2000 Stephen Cohen |
Shameful emissions The Supreme Court weighs whether the EPA overstepped its authority -- and public health hangs in the balance...  |
Food Processing October 2011 Dave Fusaro |
Editor's Plate: Where's the FDA's New Funding? The Food Safety Modernization Act has become one of the victims of feuding in Washington. Is good enough good enough?  |
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.  |
The Motley Fool May 20, 2010 Brian Orelli |
FDA Transparency! A Big Win for Investors The Food and Drug Administration has possibly just made things easier for investors. Let's just hope drug companies don't shoot it down.  |
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 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.  |
Food Processing May 2006 David Joy |
Regulatory Issues: FDA may cut food-contact program The agency's proposed budget may mean an end to the efficient and speedy Food Contact Notification Program -- and two- to five-year waits for reviews.  |
Food Processing November 2007 David Joy |
Regulatory Issues: New rules on reporting contamination Manufacturers will not have the option of handing recalls quietly. Information may even appear on FDA's web site.  |
Food Processing May 2012 David Phillips |
Dairy Plants Ready for Food Safety Modernization Act In 2000, BGC Manufacturing's Southwest Dairy plant developed a hazards analysis and critical control points plan with help from a consultant. The plan would ultimately assist the company in meeting the requirements of a sweeping new package of food safety laws.  |
Food Processing June 2007 David Joy |
Regulatory Issues: Labeling reconsidered for irradiated foods Under FDA's current regulations, only certain foods can be irradiated and at specified maximum doses. But the agency recently proposed to relax its regulations.  |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.  |
Pharmaceutical Executive February 1, 2012 Jennifer Ringler |
Industry Trees are Falling, But is FDA Around to Hear? Experts weigh in on FDA's long-awaited social media guidelines.  |
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 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  |
Food Engineering January 6, 2008 |
Regulatory Watch Push for larger FDA food safety budget... Study urged on food from cloned animal...  |
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, 2012 Gorsen et al. |
OTC Crunch Time in California Over-the-counter products face a new wave of regulation.  |
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.  |
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.  |
Bio-IT World April 15, 2003 Janet Woodcock |
FDA Director Explains the Changes The head of the Center for Drug Evaluation and Research discusses why the FDA is now kinder and gentler about Part 11 compliance.  |
Prepared Foods June 5, 2007 Mark Hostetler |
Regulations: Corn Oil Claims The FDA approves a health claim relating to corn oil and reduced risk of heart disease and changes to irradiation regulations.  |
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 March 1, 2012 Jill Wechsler |
When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications.  |
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 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?  |
Bio-IT World April 15, 2003 Heller & Philbin |
Part 11: The FDA's New View The FDA now has a softer perspective on enforcement, but companies will still have to watch their step.  |
Chemistry World February 14, 2012 Rebecca Trager |
FDA proposes biosimilars approval pathway The US Food and Drug Administration has released its long awaited guidance to assist in the development and approval of so-called 'biosimilars' - biological drugs that are very similar to licensed ones.  |
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.  |
The Motley Fool March 5, 2009 Brian Orelli |
The Dilemma for Drugmakers There's no safe place to hide.  |
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 September 1, 2008 Jill Wechsler |
Foreign Affairs FDA missteps and global outsourcing are drawing Congressional scrutiny and prompting new oversight approaches.  |
The Motley Fool January 28, 2005 Karl Thiel |
Will the FDA Kill Biotech? Proposed legislation could spell changes across the pharmaceutical world. Investors are right to be nervous.  |
Bio-IT World April 15, 2003 Barbara Depompa Reimers |
Easing the Pain of Part 11 Costs for complying with FDA electronic records regulations will cost millions of dollars per company by 2006. Risk-based processes can lighten the load.  |
The Motley Fool February 22, 2008 Brian Orelli |
Supreme Court Gives Health-Care Companies a Boost Medical device maker Medtronic celebrates a Supreme Court ruling in its favor; industry and investors will win in the long term.  |
Pharmaceutical Executive December 1, 2010 Ansis Helmanis |
A New Twist in the Cost Curve The strict regulatory divide between market authorization and price reimbursement is crumbling in the US. Is industry prepared to adapt or challenge?  |
Pharmaceutical Executive August 1, 2014 Jill Wechsler |
Social Media Struggles Continue Tweeting limited, corrections okay, says FDA, as industry, regulators wrestle with the digital world.  |
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.  |
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 December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes  |
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.  |