Under the Application Integrity Policy, the most recent action, the FDA has stopped all scientific review of any new or pending drug approval applications containing data from the Paonta Sahib plant.
But until now the FDA has focused the bulk of its attention on studies that lead to a new drug's approval and to new marketing claims, not to systematic efforts to pick up new side effects.
In fact, a supergeneric will sometimes need a completely new drug application in order to gain approval from the Food and Drug Administration (FDA).
Last night, the Food and Drug Administration announced the approval of Kynamro, a new drug to lower cholesterol in patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic disease that causes sky-high cholesterol levels and heart attacks at a young age.
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The New Drug Application for this drug was filed in 2005, and approval, which was not certain, took over 5 years.
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Novartis had high hopes for Zelnorm, a new drug it put up for FDA approval two years ago.
The approval of a new drug, made by Germany's Schering AG (nyse: SHR - news - people ), has been delayed as a result of the controversy.
Genentech (nasdaq: DNA - news - people ) and Novartis (nyse: NVS - news - people ) are nearing approval for their new drug Xolair, the first bioengineered drug for severe asthma.
Today, Bristol-Myers (nyse: BMY - news - people ) and ImClone (nasdaq: IMCL - news - people ) submitted a new application for approval of the drug, far sooner than many skeptics had predicted.
Give pillmakers the option of sending a new drug to a nongovernment testing lab for approval.
The U.S. Food and Drug Administration approved the new drug in 46 days--the fastest approval time ever.
Cut to October 2001 and the same restaurant: Gilead's new HIV drug, Viread, has just won approval, and Martin focuses again on his top scientist, who is giddy and grinning.
Some key background: In May 2003, Paddock filed an Abbreviated New Drug Application (ANDA) with FDA for approval of a generic version of AndroGel, as did another generic producer, Watson Pharmaceutical.
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If Medicaid were a new medicine applying for approval from the Food and Drug Administration, it would be summarily rejected.
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Within weeks of winning regulatory approval in March for its new schizophrenia drug, Pfizer Inc. was plying doctors with brochures and free samples.
This week, America's Food and Drug Administration gave its approval to a new type of artificial heart made by Abiomed, a firm based near Boston.
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As a patchwork solution, some drugmakers first seek approval of a new single-ingredient drug that contains a new active moiety in order to secure five years of exclusivity.
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Late yesterday, the drug giant recieved approval for Sutent, a new anticancer pill, for both stomach and kidney tumors.
Even though some doctors have been using Avastin to treat age-related macular degeneration, Genentech developed and received FDA approval in 2006 for Lucentis, a new drug specifically designed for that disease.
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In contrast, most large clinical trials are funded by drug companies in order to secure regulatory approval for new products.
King got U.S. Food and Drug Administration approval in 2003 for pediatric doses of AtroPen and new labeling and packaging for consumers, as opposed to then-existing military labels.
In retrospect, that timing was particularly remarkable for a drug that was produced with a revolutionary new technology, and that after approval would be available in pharmacies nationwide to millions of American diabetics.
Merck and Schering-Plough have received approval from the Food and Drug Administration to market Zetia, a new cholesterol drug.
Furthermore, the FDA granted approval for these two new drugs quickly, which also reduced the costs of drug development.
Aventis, the only big drug firm claiming to have a new class of antibiotic that's likely to win approval soon, is still held up after a two-year regulatory delay.
But they are not now applying for approval for this use, because the FDA is nervous about releasing an exotic new drug for such a large group of patients until it has been studied on more people.
Back then, a new drug to treat the pain of arthritis would only need to complete 90 days of continuous testing before approval.
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Lilly (nyse: LLY - news - people ) moved a little farther along in its comeback story Monday when it received conditional approval from the U.S. Food and Drug Administration for Cymbalta, a new antidepressant.
Currently, the FDA awards only three years of exclusivity if a fixed-dose combination drug contains a previously approved ingredient, and if a drugmaker conducted new clinical studies that were essential to approval.
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For one thing, it signals that these companies are finding ways of using these new technologies to make their medicines more effective --making for better odds in getting Food and Drug Administration approval and reducing money wasted testing drugs that won't work in human beings.
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