GPC's Date With the FDA
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A document released by the FDA outlines its concerns with GPC's lead drug.
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WASHINGTON : A skin patch providing sexual stimulation for menopausal women that promises to do what Viagra did for men will begin its approval procedure on Thursday at the Federal Drug Administration (FDA).
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TUESDAY, Nov. 16 (HealthDayNews) -- U.S. Food and Drug Administration officials insisted Tuesday that medical evidence, and not political pressure from conservative groups, prompted their decision Monday to order the most stringent safety labeling for RU-486, the abortion pill.
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Merck &amp; Co. Inc. Chief Executive Officer Raymond Gilmartin and FDA officials have been called to testify before Congress on Nov. 18 over safety problems with the company&#39;s withdrawn
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Merck & Co.MRK.N said on Friday it   has delayed filing for a high-profile combination pill designed   to lower "bad" cholesterol and increase "good" cholesterol,   while heading off a common side effect of one of the   ingredients.
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It&#39;s amazing how much we&#39;re learning these days about what the FDA knew in years past. Considering what the agency suppressed about Vioxx, antidepressant drugs, and flu vaccine contamination, I&#39;m starting
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The Food and Drug Administration (FDA) announced the availability of a qualified health claim for monounsaturated fat from olive oil and reduced risk of coronary heart disease (CHD).
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It'll be awhile before the FDA makes its decision and the stock price settles down.
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Here's what a newly approved drug looks like.
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An expert panel advising the Food and Drug Administration recommended today that antidepressants carry a warning in a black box on the label saying that the medications
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Taking a look at how drug approval rates have fared under different FDA commissioners.
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The Food and Drug Administration (FDA) today announced the issuance of a final rule on current good tissue practice (GTP), the last of three rules to be finalized as part of the Agency&#39;s overall plan to make human cells and tissues even safer.
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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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The FDA has another delay for this HPV vaccine.
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Biogen Idec Inc. of Cambridge said it is in final discussions with the Food and Drug Administration about its new multiple sclerosis drug Antegren, and expects the drug to be approved by the end of the month.
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GlaxoSmithKline is expected to start the process of publicly posting the results of clinical trials for its marketed drugs.
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The Food and Drug Administration (FDA) has granted a fast track review of testosterone patches for women with low sex drive, despite concerns about insufficient data and potentially misleading marketing by their manufacturer Proctor &amp; Gamble, claim two