Three recent developments at the FDA will further increase the time and cost of drug development.
What should the FDA do about crackpot beliefs that inspire people to buy overpriced juice?
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 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.
This month, the FDA issued new draft guidance on liver toxicity for experimental drugs.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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Schering-Plough is working on the control problems with the FDA and should have them resolved shortly.
So unless the FDA grants its request, the biotech is stuck with three years of exclusivity.
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But there is good reason, though, why the FDA move is incremental at best.
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The FDA is adamant, though, that the organic stuff is far from in the clear.
The FDA researcher was a steadfast watchdog on drug safety long before the Vioxx recall.
The full FDA press release and a link to the FDA web site are below.
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The FDA looked at tightening device rules in the early 1990s, but Congress undercut the effort.
The FDA continues to monitor the mercury threat and could revise its consumption recommendations.
The FDA gave the drug "priority review, " which means a decision was due in six months.
It's important that the FDA does not prevent cheaper generic drugs from getting to market.
That allowed Mr. Liang to review documents as they passed through the FDA approval process.
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