Drug maker tells FDA panel that Intrinsa is safe
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(WASHINGTON) - The maker of a new drug to treat women&#39;s sexual dysfunction says the product is safe and should be approved without delay.
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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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A top Republican lawmaker raised  concerns about the U.S. Food and Drug Administration's ability  to monitor drug safety following Merck & Co. Inc.'s recall of  its arthritis drug last week, according to a letter made public  on Tuesday.
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The Food and Drug Administration is strengthening warnings about the possible risks of a popular arthritis drug. Bextra, which is made by Pfizer Inc.
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The FDA issues a health advisory for a top Pfizer drug.
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The public should have reasonable expectations that medicines the Food and Drug Administration has approved for the market are, in fact, safe.
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The Food and Drug Administration needs more staff, funding and authority over the drug industry to better track the safety of medicines after they reach the market, an Institute of Medicine report said Friday.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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Proctor &amp; Gamble, the company behind a testosterone patch called Intrinsa, hoped to have the first female Viagra equivalient on the market but after reviewing the research, an FDA advisory committee said &quot;no&quot;.
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Users of an anti-arthritis drug linked by a study to an increased risk of heart attacks and strokes have been urged not to panic. The UK Department of Health said users of Celebrex, manufactured by US drug
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ROCKVILLE, Md.  - 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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U.S. FDA staff reviewers on Tuesday  said data on a new non-Hodgkin's lymphoma drug made by Inex  Pharmaceuticals Corp. and Enzon Pharmaceuticals Inc. may be  unreliable due to the trial's structure and size.
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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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Cheaper versions of biologic drugs can be made safely, a U.S. Senate panel heard on Thursday, but brand-name makers of the pricey therapies for cancer and other diseases warned substitutes could be risky.
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Shares of Oragenics Inc. jumped after the biotechnology company reported Tuesday that the Food and Drug Administration allowed it to proceed with safety trials on a lifelong tooth decay protection rinse that
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NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
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Startling testimony by an FDA drug safety reviewer about five popular medications has the medical world buzzing about how tightly the agency should be regulating new medications.