Negative briefing documents from FDA staff hardly represent a death knell for a drug.
Three recent developments at the FDA will further increase the time and cost of drug development.
The same year Tamiflu, an influenza drug it codeveloped with marketing partner Roche, got FDA approval.
What should the FDA do about crackpot beliefs that inspire people to buy overpriced juice?
But these are unusual times for drug development and its regulation by the Food and Drug Administration (FDA).
The FDA has been rocked by a series of scandals over the last decade.
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Any guest speaker invited by the FDA must undergo screening for conflicts of interest.
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The FDA ruling could do much to get the technology on the fast track.
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The usual FDA bottleneck could be loosened with the first incorporation into a bonafide drug.
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"We're not trying to burden tanning salons, " said Dr. Jeffrey Shuren, FDA's director for medical devices.
The Indoor Tanning Association released a statement following the FDA's announcement on Monday.
The FDA had this power under the 1984 Waxman-Hatch law, designed to speed up drug approvals.
Last week, the FDA was prepared to lift the prescription requirement for Plan B One- Step.
The FDA says the drugs clearly shorten survival and speed the progression of cancer.
The FDA has approved more than 70 drugs over the last two years.
The FDA is heavy into their investigations so reports will be dribbling out over time.
For many years, the key hurdle to achieving success in drug development was FDA approval.
This month, the FDA issued new draft guidance on liver toxicity for experimental drugs.
The FDA bans the nonsteroidal anti-inflammatory drug (NSAID) Phenylbutazone (Bute) in all food-producing animals.
The FDA will be taking comments on the proposed ruling for the next 90 days.
Second, I think the FDA should adhere to the efficacy criteria it set up in advance.
Could the European approval result in more pressure on the FDA to change its mind?
This would give rival companies a better idea of what the FDA wants, speeding drug development.
Those recommendations won't be binding, but the FDA is extremely likely to follow them.
Few scholars who study the FDA would agree that the agency has promoted innovation.
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These claims haven't been proven yet though, and shocking your own cranium isn't exactly FDA approved.
Second, they have been acquiring biotechnology companies that recently received FDA approvals with promising drugs.
Clarinex, once expected to get FDA approval this year, now may not get clearance until 2002.
Schering-Plough is working on the control problems with the FDA and should have them resolved shortly.
Porges points out that there is an FDA-mandated safety study of Copaxone in combination with Tysabri.
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