March 22, 2019fdaaa

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Hearts Seen Whole

A Case For Centralized ECGs

March 26, 2009

Is the pharmaceutical industry managing and assessing electrocardiograms (ECGs) as rigorously as it could? As consistently as it should? Should the FDA transition away from paper ECGs? Jeffrey Litwin has a delicate line to walk. On the one hand, as chief medical officer and executive vice president of ERT (until recently known as eResearch Technology), his company offers unique systems and personnel to manage ECGs in a centralized manner. On the other hand, he can't flatly say the existing burden of regulation on the industry is insufficient. "Most of the focus has been on the QT interval," allows Litwin, a cardiologist. "It's great we have some guidance to do something for QT. There is not very much focus on other safety issues." One example is morphology in the ECG, or the displacement from a normal trace. Another is the variability between reviewers who are not rigorously trained to interpret ECGs in…more...

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Can Pharmacovigilance Scale?

Data-Mining 12 Million Lives

January 20, 2009

Twenty six patients. Eleven patients. Three patients. Despite the billions spent on clinical research, regulatory decisions often boil down to adverse events in a handful of patients. There are widely divergent…more...

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Frustrated Justices

Supreme Court Mulls Drug Labels

November 20, 2008

As many readers know, the Supreme Court is considering the case of a Vermont musician, Diana Levine, who lost an arm when a physician assistant didn’t fully consider the label on…more...

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FDA Needs IT

Throckmorton at RAPS Meeting

October 27, 2008

Like the industry it regulates, the FDA finds itself in a slowly closing vise—squeezed between a mission that never seems to get much narrower and a budget that never gets much…more...

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Ready for REMS

Relsys On Managing Safety

August 25, 2008

One curiosity of the drug safety controversies of the past few years is the low profile of most of the software companies in the niche. One could read the newspaper or your favorite business magazines and imagine that the industry didn’t have people or systems to manage and predict adverse events, that Medwatch paperwork and other forms…more...

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Rejecting Schering's Sugammadex

Pre-Election FDA On Lockdown

August 06, 2008

A while back, we checked in with someone who makes a living suing the pharmaceutical industry. This week, we worked the other side of the street, chatting with Mark Mansour of Bryan Cave, where he runs the FDA practice group in the firm’s Washington, D.C. office. Mansour has been perplexed, he reports, at the non-approvable letter that…more...

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'Absolutely overwhelming'

FDAAA Update At DIA

July 08, 2008

The Food and Drug Administration Amendment Act of 2007 (FDAAA) is vast. And overwhelming. At least one FDA official seems daunted by it, nine months after it became law. Take Sandra Kweder, deputy director of the FDA’s Office of New Drugs. Last month, at the 2008 Drug Information Association (DIA) conference session on how FDAAA will impact…more...

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New Woodcock Role?

PhRMA Safety Surveillance Pilot

July 03, 2008

Just as the FDA has received the resources to make a major push into post-marketing drug-safety surveillance under the Food and Drug Administration Amendment Act (FDAAA), the Pharmaceutical Research and Manufacturers of America (PhRMA) says it’s doing the same thing. PhRMA…more...

New FDAAA Paperwork

New FDA Form 3674, Explained

The FDA’s new Form 3674 is an attestation that a trial has been registered in clinicaltrials.gov.

REMS Risks

FDA’s Woodcock On FDAAA

At Outcome’s Post-Approval Summit at Harvard, CDER head Janet Woodcock walked the audience through what FDAAA means.

Business As Usual

Wyeth on FDAAA

Joseph Camardo spoke at the Post-Approval Summit at Harvard, and was wicked smart. Even so, what he didn’t say perturbed us.

Wednesday News Briefs

Cardiac Testing Coalition

With news about Pfizer, health-IT legislation, Infermed, and the FDA Science Board.

Three Ticking Clocks

Bayer Halts Trasylol Sales

With journal editors in charge of drug safety, the political system has failed the industry and the public.


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