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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.
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.
Bio-IT World January 12, 2004 Bob Violino	What's the Problem? Validating computer systems is unavoidable. Here's how to pass FDA inspections while minimizing validation time and cost.
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 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 This month FDA released its draft guidance on the use of "Interactive Promotional Media."
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 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.
IndustryWeek October 19, 2011	FDA: A Future Innovation Partner? Could the Food and Drug Administration reform itself to help manufacturers create new medical technologies?
Bio-IT World January 12, 2004 Steve Lefar	Systematize Your Regulatory Info! Want better protection against regulation breaches? Build a system that engenders 'grassroots' compliance.
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
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.
Information Today September 13, 2012 Joanna Ptolomey	Regulatory Compliance Shifts the mHealth Applications Market The market for medical apps that go through FDA clearance is currently small, but is expected to dramatically increase. The FDA is expected to issue detailed guidelines about mobile health devices and apps and their regulation in late 2012.
Pharmaceutical Executive November 1, 2006 Jill Wechsler	Washington Report: Waiting for Advice Companies are increasingly turning to the Division of Drug Marketing, Advertising and Communication (DDMAC) for opinions on ad materials. That's a good thing. What's bad is that DDMAC has slowed to a crawl.
Prepared Foods October 2007 Mark Hostetler	Article: Regulations: Scientific Health Claims Review FDA's draft guidance on evidence-based health claims is aimed to help producers evaluate and understand the strength of evidence in supporting health claims.
The Motley Fool September 9, 2010 Brian Orelli	Will These Drugs Get Past the FDA This Month? See what the FDA has on its decision calendar for the rest of September.
The Motley Fool June 8, 2011 Frank Vinluan	Lorillard Hires FDA Official to Tackle Tobacco Regulation The hire of Wilcox comes as menthol cigarettes are expected to come under stricter FDA scrutiny.
The Motley Fool December 27, 2010 Brian Orelli	FDA Kicks Dust on Alimera's Fairy Tale Eight months after its IPO, Alimera gets hammered.
The Motley Fool February 16, 2010 Brian Orelli	For Blockbuster Cancer Drugs, Approvals Are the Easy Part Don't get too excited. As an investor, you can lower your risk by investing in cancer drug companies after a clinical trial success but before an FDA approval, but you'll also reduce your reward.
Pharmaceutical Executive December 1, 2011 Jill Wechsler	FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes
Pharmaceutical Executive June 1, 2009 Jill Wechsler	A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight.
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 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.
Bio-IT World January 12, 2004	PDMA Compliance in 12 Steps Prescription Drug Marketing Act violations can cost millions. To save that money, follow this program.
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.
Bio-IT World September 2005 Mark D. Uehling	Murky Diary Entries The FDA is planning to clarify the degree to which existing patient diary technologies are (or are not) encroaching on data-management duties formally assigned to clinical investigators. That guidance is in the works, with no known timetable.
Bio-IT World June 12, 2002 Malorye Branca	FDA Fosters Pharmacogenomics One reason pharmaceutical companies have been slow to embrace pharmacogenomics is the fear that it will be difficult to get such products through the FDA. Lawrence J. Lesko, director of the FDA's Office of clinical pharmacology and biopharmaceutics, talks about his hopes for the field.
The Motley Fool February 3, 2010 Brian Orelli	Pfizer's Hedge Pays Off FDA wants more data from Pfizer's partner, Protalix on their treatment for Gaucher disease.
The Motley Fool February 25, 2011 Brian Orelli	Minor Delay, Major Missed Opportunity Protalix and Pfizer's Gaucher disease drug gets delayed.
The Motley Fool December 28, 2010 Brian Orelli	Double-Digit Increase! Haven't We Learned Anything? MannKind's investors need a history lesson.
Pharmaceutical Executive February 1, 2013 Jill Wechsler	Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending.
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 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.
Bio-IT World April 15, 2003 Paul Bleicher	E-Sourcing: Covering the Regulatory Bases Capturing clinical source data electronically can hit a home run for trial efficiency and safety -- but access control is key. Here's an expert guide.
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 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 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.
The Motley Fool August 23, 2010 Brian Orelli	No Way to Jazz Up This Result Jazz Pharmaceuticals investors went from ecstatic to devastated in less than a week.
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?
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.
Fast Company Neal Ungerleider	Why Kim Kardashian's Instagram Post Was In Violation Of FDA Rules Her paid endorsement did not make mandatory statements about Diclegis' side effects and comply with the same rules that require spoken disclaimers at the close of television commercials for prescription drugs.
Bio-IT World July 2005 Scott Lundstrom	Indicators Point to Spending Gains Life science organizations expect an average 4.6% increase in their IT spending over the next 12 months. It marks the fourth consecutive quarter in which life science organizations expressed expectations for IT spending growth.
The Motley Fool August 18, 2011 Brian Orelli	Running the Correct Trial Isn't Enough MELA Sciences' stock is up on claim that their trial meets FDA guidance, but they still need to prove that the device actually works.
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.
The Motley Fool April 5, 2010 Brian Orelli	1 Month to Go! Is Dendreon a Buy? Only if you understand the risks.
Bio-IT World August 13, 2003 Brian Reid	Remaking the FDA New commissioner is pushing for greater use of technology and innovation to speed the flow of drugs to market.
The Motley Fool April 24, 2008 Brian Lawler	FDA Stings Genzyme Earnings A nasty surprise hurts the drug developer's first quarter results.
The Motley Fool March 5, 2008 Brian Orelli	FDA (Indirectly) Thwacks Amylin The FDA's draft guidance puts a cloud of uncertainty over the makers of diabetes drugs.
The Motley Fool September 6, 2005 W.D. Crotty	An Anxious Time for Andrx Questions about its manufacturing lead the FDA to take action. The generic drug company's stock was the largest percentage loser on the Nasdaq this morning.
The Motley Fool December 2, 2010 Brian Orelli	A Short FDA Delay. For What? GlaxoSmithKline and Valeant aren't saying.
The Motley Fool October 31, 2007 Brian Lawler	Adams On-and-Off With the FDA A new compound gets delayed, but the drugmaker still raises earnings guidance, and shares rise. Investors, take note.