Agency doctors say post-market studies can&#39;t be required
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WASHINGTON (CBS.MW) -- The US Food and Drug Administration could not force Merck to perform safety studies of arthritis drug Vioxx after it hit the market in 1999, but the agency successfully &quot;negotiated&quot; the long-term studies that uncovered Vioxx&#39;s heart
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Many clinical cancer trials are not published in order to keep industry secrets. A British cancer research group calls for all studies to be published -- even those with marginal results -- so doctors are not misled.
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Guidelines released Monday by  the American College of Chest Physicians (ACCP) indicate that  at present lung cancer screening with CT scanning and other  methods is generally not warranted outside of research studies.
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Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior
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A study reveals most doctors do not believe changes to out-of-hours services have improved patient care.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way the agency monitors safety risks of medicines after they  hit the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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A top Food and Drug Administration  official said on Thursday she disagrees with an agency  scientist's warning that five drugs on the market have  significant safety risks.
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Drug makers will not need regulatory approval for every change in their manufacturing processes under new guidelines designed to prevent supply disruptions, U.S. health officials said on Wednesday.
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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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The US Food and Drug Administration (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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Neurologists urge caution upon reports of a successful therapy.
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Agency asked manufacturers not to labeling drugs as ineffective in children, citing information might scare public away from the drugs.
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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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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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The safety of Merck&#39;s (MRK:NYSE - news - research) Vioxx has been questioned again with the posting of an internal Food and Drug Administration study on the agency&#39;s website.
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&quot;...the agencyâs senior management is more concerned with external appearance than rigorous science.&quot; -- Dr. Richard Horton, editor, The Lancet.
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WASHINGTON - The Food and Drug Administration silenced one of its drug experts who raised safety concerns weeks before Merck & Co. yanked the blockbuster drug Vioxx due to increased risks for heart attack and strokes, the chairman of the Senate Finance Committee said Thursday...