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Fast Company
November 2004
Scott Kirsner |
A Slow, Patient Pace A follow-up to a recent story on a pacemaker that helps patients with epilepsy and seeks additional approval for patients who suffer from severe, drug-resistant depression -- including comments from the parents of a six-year-old epileptic who is using the device.   |
IEEE Spectrum
May 2005
Samuel K. Moore |
Zapping Away The Blues Cyberonics Inc. plans to introduce the first implanted device that can treat a psychiatric illness. |
The Motley Fool
February 4, 2005
Stephen D. Simpson |
Cyberonics' Depression Zapper Medical technology company gets a much-needed boost from the FDA. |
IEEE Spectrum
March 2006
Samuel K. Moore |
Psychiatry's Shocking New Tools Electronic implants and electromagnetic pulses are picking up where psychoactive drugs have failed. |
The Motley Fool
June 16, 2004
W.D. Crotty |
Nothing Depressing Cyberonics Cyberonics Gets FDA nod; shareholder Boston Scientific gets a portfolio boost. |
BusinessWeek
March 7, 2005
Michael Arndt |
Rewiring The Body First came pacemakers. Now exotic implants are bringing new hope to victims of epilepsy, paralysis, depression, and other diseases. And some of the biggest names in health care are in a scramble to get into the market. |
IEEE Spectrum
October 2008
Samuel K. Moore |
U.S. Regulators Approve Magnetic Stimulation Device for Depression Neuronetics' repetitive transcranial magnetic stimulation wins long battle for FDA approval. Questions remain about whether insurers will pay for it |
BusinessWeek
March 7, 2005
Michael Arndt |
"Pacemakers" for the Rest of You Slews of tiny devices that deliver electrical stimulation to a wide variety of organs should soon become available. |
BusinessWeek
May 2, 2005
Kate Murphy |
Easing Depression Without Drugs Doctors are trying therapies, from implants to herbs, that can cut down on side effects. |
The Motley Fool
February 8, 2005
Stephen D. Simpson |
Cyberonics Looks to the Future Shifting resources to the launch of a depression therapy will hurt now, but should pay off later. Investors looking to take on some risk in exchange for an aggressive growth opportunity might want to explore this one. |
Popular Mechanics
May 2006
Logan Ward |
Your Upgrade Is Ready Evolution has done its best, but there's a limit to our bodies capabilities. Wanna be Superman? Better call the engineers. |
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. |
Salon.com
March 2, 2001
Dawn MacKeen |
Your heart has been recalled In the brave new world of body-part implants, what happens when you get a lemon of a ticker? |
The Motley Fool
November 22, 2005
Stephen D. Simpson |
Cyberonics' Ride Not Over Yet One way or another, this medical device maker's stock is almost certain to produce more volatility in the years to come. |
American Family Physician
July 1, 2001
Selim R. Benbadis |
Advances in the Treatment of Epilepsy Significant advances have been made in the diagnosis and treatment of epilepsy over the past decade... |
The Motley Fool
December 31, 2010
Brian Orelli |
2010 FDA Approvals and a Look Ahead Recent history can help us handicap FDA decisions. |
The Motley Fool
February 4, 2009
Brian Orelli |
Not If, but When, for Lilly At least Lilly now knows that it's just a matter of time until the anti-clotting agent wins FDA approval. |
American Family Physician
July 1, 2001 |
What Should I Know About Seizures and Epilepsy? What is a seizure, and what is epilepsy?... What causes epilepsy?... Who gets epilepsy?... Are all seizures the same?... How does the doctor find out I have epilepsy?... |
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. |
The Motley Fool
June 1, 2005
T.G. Wolf |
A Shocking Opportunity? Advanced Neuromodulation Systems has been competing quite nicely with the big boys in the emerging neurodevice segment of the neurotech industry. Investors, take note. |
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? |
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. |
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
December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. |
Pharmaceutical Executive
March 1, 2013
Jill Wechsler |
Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year. |
The Motley Fool
August 24, 2009
Brian Orelli |
J&J Would Rather Not Say Drug delayed, reason unknown. Should shareholders be worried? It's hard to tell. |
The Motley Fool
August 17, 2007
Brian Orelli |
Fewer Drug Approvals? Buy! Stricter standards at the FDA could create a buying opportunity. Drug approvals are down one third this year, creating a lot of value in pharmaceutical and biotech companies. Just choose your medicines carefully. |
The Motley Fool
December 31, 2007
Brian Lawler |
The Anatomy Of An Approved Drug An independent audit by the FDA provides a useful summary of the characteristics of drugs approved by the agency. |
BusinessWeek
October 1, 2009 |
Stalking the Future J&J lost patent protection on epilepsy and schizophrenia drugs worth $7 billion last year. These new drugs, if cleared by the FDA, could help offset the damage. |
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. |
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
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
January 14, 2008
Brian Lawler |
Score One for Dendreon and Disclosure A prestigious journal supports Dendreon's potential prostate cancer treatment, and makes a compelling case for more FDA disclosure. |
Reason
April 2004
Todd Seavey |
Regulation for Dummies A book about the FDA. |
American Family Physician
September 1, 2000
Gary N. McAbee & James E. Wark |
A Practical Approach to Uncomplicated Seizures in Children Uncomplicated seizures and epilepsy are common in infants and children. Not all uncomplicated childhood seizures require neuroimaging or treatment... |
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. |
Fast Company
April 2004 |
Between The Lines Homeland Security... (Non)Standard Operating Procedure... Comic Relief... |
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. |
BusinessWeek
June 26, 2006
Jane Sasseen |
Another Dodgy Way To Dole Out Options Grants intentionally timed to good news are becoming the focus of greater scrutiny. |
Pharmaceutical Executive
January 1, 2006
Clinton & Wechsler |
What Ever Happened to Critical Path FDA's ambitious program to improve drug development disappeared from view almost as soon as it was announced. Suddenly, it's back, but is it here to stay? |
Pharmaceutical Executive
December 1, 2006
Richard A. Epstein |
FDA vs. the Individual In this excerpt from his important new book Overdose, an ever controversial legal scholar argues that the current system overvalues risk, ignores individual differences, and deprives patients of valuable treatments. |
