FDA Sets Deadline for Unapproved Medications
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Manufacturers of unapproved extended-release cough and cold drugs that contain an expectorant called guaifenesin have until Nov. 25 to stop shipping the medications, health officials said yesterday.
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It takes another run at getting FDA approval for its lead drug.
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A day late and possibly several millions of dollars short. That's the scenario facing one drug manufacturer unless it can get a helping hand from Congress.
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The Bush administration missed a deadline Wednesday to give Congress a report on prescription drug imports, a day after it finalized a deal to buy flu vaccine made in Germany.
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The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will meet early next year to review the safety of a class of drugs, COX-2 inhibitors, used to treat arthritis and pain.
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The Food and Drug Administration (FDA) learned yesterday from AstraZeneca that a large clinical trial comparing Iressa (gefitinib) with placebo in patients with non-small cell lung cancer who had failed other courses of cancer therapy showed no survival
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Momenta announces a delay in the FDA review of its lead drug.
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The regulatory approval was also a boost for the embattled drugs sector. It was feared that, following a series of safety crises, the US Food and Drug Administration would get tougher on new drugs.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way it monitors safety risks associated with medicines already on the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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New reports suggest another drug company moved too slowly to pull a dangerous medication from the market and question the Food and Drug Administration&#39;s ability to protect the public.
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The US Food and Drug Administration (FDA) issued a warning about the generic drug naproxen, after the National Institutes of Health (NIH) halted a clinical trial involving patients at risk of developing Alzheimers.
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WASHINGTON -- Pharmacists who custom-blend drugs from bulk ingredients based on a doctor's prescription do not create new unapproved drugs, a federal judge in Texas said, undercutting the Food and Drug Administration's attempts to regulate the practice, known as compounding.
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The U.S. Food and Drug Administration on Thursday approved a medical device maker's request to sell at-home heart defibrillators without a prescription.
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U.S. regulators on Tuesday ordered companies to stop selling unapproved drugs containing quinine, which is approved only in one anti-malaria drug and can have serious side-effects.
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The US Food and Drug Administration is pushing for an expanded review of MDS Pharma&#39;s generic drug studies at its Montreal laboratories, and has requested a meeting with the company to discuss its concerns.
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LONDON, October 6  - AstraZeneca (AZN.ISE) has delayed the regulatory approval filing target for its diabetes drug, Galida, from 2006 to 2007, while admitting that its anti-blood clotting drug, Exanta, was unlikely to receive the US
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WASHINGTON -- The Food and Drug Administration, seeking to ease a major shortage of flu shots, is in discussions with two companies that sell flu vaccine in Canada and elsewhere, and have found a few million unsold doses.