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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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 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to review the way it monitors safety risks associated with medicines already on the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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German drug maker Altana said that it had postponed its application for approval of its new asthma treatment Roflumilast in the United States because additional clinical trials on the drug were taking longer than expected.
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Drug companies could soon make more experimental drugs available for a fee to more patients with serious or life-threatening diseases that have no approved treatments, under revised rules the U.S. Food and Drug Administration proposed on Monday.
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The Food and Drug Administration, concerned about the number of children being accidentally overdosed on over-the-counter cough and cold medicines, yesterday warned parents never to give children younger than age 2 such products without a doctor's approval.
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Momenta announces a delay in the FDA review of its lead drug.
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GAITHERSBURG, Maryland  - The Food and Drug Administration should consider telling patients and doctors that the use of drug-coated heart stents in unapproved, high-risk cases can lead to greater complications, a panel of medical experts said on Friday.
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Novartis AG, Switzerland&#39;s largest drugmaker, said the US Food and Drug Administration has delayed approval of its Certican transplant treatment and is seeking more information on safe and effective dosing.
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MONTPELIER, Vt. The Food and Drug Administration has postponed its response to Vermont&#39;s first-in-the-nation lawsuit over the importation of prescription drugs from Canada.
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The FDA, which has been under criticism for its lengthy approval process, this week approved two new drugs for multiple sclerosis and cancer treatment.
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A Fool's prediction on the FDA's impending decision on approval.
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Companies have 60 days to stop selling unapproved prescription drugs made with quinine and dispensed by the millions each year.
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BOSTON (CBS.MW) -- The US Food and Drug Administration may soon take legal action against states that insist on importing prescription drugs from foreign drug retailers, a senior agency official says.
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The Food and Drug Administration is considering allowing pharmaceutical makers to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for "off-label" purposes.
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Because of PfizerÂs failed trial, drugs similar to torcetrapib from other companies could face greater scrutiny Â and delays Â in getting to market.
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WASHINGTON The Food and Drug Administration has agreed to allow broader application of a breast cancer drug. The drug (letrozole) is currently used against advanced breast cancer and the FDA will now allow