Companies are increasingly turning to DDMAC for opinions on ad materials. That's a good thing. What's bad is that DDMAC has slowed to a crawl.
Nov 1, 2006
By:
Jill Wechsler
Long turnaround on ad reviews adds new complications to the process of developing marketing plans.
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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?
Oct 1, 2006
By:
Jill Wechsler
Pharmacists have applauded Plan B's behind-the-counter status, and FDA hints that the drug might pave the way for more pharmacy-only OTC products.
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A new wave of collaborations between industry, non-profits, and government seeks affordable treatments for neglected diseases around the world.
Sep 1, 2006
By:
Jill Wechsler
The PPP approach asks pharma to identify promising drugs and conduct pre-clinical tests, instead of paying for costly late-stage clinical trials.
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FDA's most aggressive critic in Washington is Iowa Senator Charles Grassley. In this exclusive Pharm Exec interview, he explains where the agency goes wrong—and what he would do to fix it.
Sep 1, 2006
By:
Jill Wechsler
If I ran the FDA, I'd have a Rose Garden ceremony for all the histleblowers in my agency. No one can know where all the skeletons are buried. We ought to honor every one of those patriots.
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Aug 1, 2006
By:
Jill Wechsler
Pharma restrictions of sales tactics vary from state to state, creating new compliance challenges.
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The push for more useful information on medication effectiveness is shaping drug development and reimbursement.
Jul 1, 2006
By:
Jill Wechsler
Pharma companies fear CMS' new Medicare policy will routinely require post-approval studies in order to gain reimbursement for new drugs. CMS says it is expanding payment for "promising but not persuasive" drugs.
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Congress wants pharma to meet study commitments and disclose research results, but no one is giving FDA more resources to enforce its rules.
Jun 1, 2006
By:
Jill Wechsler
Pharma follow-through? As of September 2005, drug manufacturers had promised to perform 1,200 post-marketing studies. Companies hadn't even started 65 percent of them, and only 200 were completed.
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FDA has finally released its long-awaited list of research opportunities for the Critical Path initiative. Now comes the hard part, as companies learn how to collaborate on projects that will benefit pharma as a whole.
May 1, 2006
By:
Jill Wechsler
The pharmaceutical companies in the Predictive Safety Consortium have agreed to cross-test each other's laboratory methods to determine which are most effective in detecting kidney, muscle, and liver toxicity.
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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?
Apr 1, 2006
By:
Jill Wechsler
FDA doesn't usually write a black box warning "without some pretty good data," said Robert Temple of FDA's Office of Medical Policy. Overuse of the black box can both dilute its impact and limit access to needed treatment.
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