HeartWare said that the FDA was requiring the company to perform a post-approval study in the form of a registry consisting of 600 HeartWare patients and an additional 600 control patients.
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Belvin's drug, from Bristol-Myers Squibb and Medarex, shrank tumors in about 10% of melanoma patients in a 2007 trial--not enough to get approval without more study.
In 1998, the year of FDA approval, a study at the Johns Hopkins Burn Center showed infection rates fell 70% when doctors switched from using uncoated latex catheters to Rochester's new device.
Approval of the study was greeted with enormous enthusiasm from scientists, child health advocates, and communities, and ideas were solicited from over 2500 scientists in different fields participating in twenty different working groups, as well as from government agencies, and communities around the country.
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Sanjay Kaul, a cardiologist at Cedars Sinai Hospital in L.A. who has been an FDA consultant, says the FDA should now require all cholesterol medicines to either do a big study showing they prevent heart problems before approval or only grant conditional approval and then demand the big study.
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In an interview, Yancy said that although the study is not enough to give Natrecor a complete stamp of approval, he thinks the study was well designed to pick up a signal of kidney side effects.
For the moment, most Wall Streeters believe an approval for the Anchor study data could come in late 2013 or early 2014.
There are plenty of reasons to delay approval until a big safety study emerges.
He proposed starting with a smaller preapproval trial to rule out risk and then doing a second, larger study, after approval.
That could make regulatory approval difficult without yet another study.
If the study results in approval for brentuximab vedotin, it will also be proof that the FDA does sometimes approve drug based on small studies, or without placebo groups.
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The study results followed regulatory approval last year of Bristol-Myers's Yervoy for advanced melanoma.
In September 2010, First Solar finally received approval for a pre-feasibility study for the first phase of the Ordos project.
Merck has so far declined to conduct a big, expensive study to establish that Gardasil can prevent HPV infection in the throat, probably because it would be difficult to use such a study to get regulatory approval from the Food and Drug Administration.
Drug companies would normally advance to a second trial before mounting a study that could lead to approval.
Celgene had previously disclosed that the study, designed to get marketing approval from the Food and Drug Administration for Abraxane in pancreatic cancer, was positive.
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This has been a tough thing to pull off but Seattle Genetics says it has been told by the Food and Drug Administration that its study could be sufficient for an approval, despite its small size.
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If AtheroGenics had set heart attack, stroke and death as the main goal of its study, these results could lead to approval by the U.S. Food and Drug Administration.
Cleveland Clinic cardiologist Steven Nissen, an early critic of Zetia, says the Food and Drug Administration should have demanded Merck begin a giant study comparing Zetia with placebo immediately upon approval.
The Advisory Committee gave mixed views about whether this outcomes study should be done before or after FDA approval.
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One study shows that when an FDA panel recommends approval, the FDA will approve the drug 97% of the time.
He questioned whether a full hydrological study would be a precondition in the possible planning approval and what conditions were likely to be attached if approval was granted.
"Afinitor is another example of the value of continuing to study drugs in additional types of cancer after their initial approval, " said Dr. Richard Pazdur, director of the FDA's cancer drug office.
But the just-released study opens the starting gate for the next stage of the approval and development process.
The approval comes after the FDA last fall had asked Amylin to run another study after expressing concerns that Bydureon may cause heart problems.
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Millennium had faced some skepticism when it said it would file for FDA approval a year ahead of its original schedule, before a larger clinical study could be completed.
The FDA based its approval of the NovoTTF 100A System on results from a single international clinical study in 237 patients with recurrent GBM or with GBM that hadn't responded to traditional therapy.
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Against that background, even with new, lowered regulatory bar for new therapeutics, it seems unlikely that approval would occur after studies of a dozen patients (the size of the study, as listed on clinicaltrials.gov).
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Merck is setting a good example by evaluating the drug in steps, carefully assessing its effect on patients, and not proceeding toward approval before testing the effect of the drug on patient outcomes in a large study.
He hopes that Inamed's clinical study will prove that its silicone implants are safe and will eventually result in FDA approval for the implants.
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