Antiperspirant Makers Sweat Out FDA's Data Request
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In June 2003, the    Food and Drug Administration  issued a final rule saying that antiperspirants, if formulated and tested properly, could safely and effectively reduce the amount of sweat coming from users -- for up to 24 hours.
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US regulators won&#39;t approve Allergan Inc.&#39;s (AGN.N: Quote, Profile, Research) experimental treatment for the skin disorder psoriasis based on the data submitted, the company said on Monday.
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European medical regulators have called on the worldâs leading pharmaceutical companies to improve their communications with authorities and surveillance of drugs, following frustration about Merckâs handling of the withdrawal of its anti-inflammatory
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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
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The FDA asks for more data about Avastin, which could be used to treat various cancers.
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Merck &amp; Co., which withdrew the Vioxx painkiller last month because of a heart risk, said yesterday that US regulators have asked for more safety data before they will approve the medicine&#39;s successor, Arcoxia.
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Physicians frequently fail to  provide patients with all the information they should have when  they're prescribed new medication, investigators in California  report.
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Nearly 20 percent of U.S. Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite their reservations about the drug's risks or effectiveness, according to documents made public on Thursday.
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A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned
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The Food and Drug Administration uncovered contamination and unsanitary conditions at a British flu vaccine manufacturing plant in 2003 but failed to re-inspect it until similar
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Europeans seek assurances that company is respecting privacy rights of people whose data it retains.
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The FDA releases its documents on Adolor's lead drug.
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Two revelations last week of Food and Drug Administration foot-dragging place in doubt whether the agency can effectively serve and protect consumers.
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The U.S. Federal Trade Commission asked generic drug manufacturers for prices, cost data and sales information to help study the short- and long-term effects of authorized generics on prescription drug competition, the agency said on Friday.
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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency's monitoring of the safety of prescription drugs now being sold.
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Biotechnology company InterMune Inc.  on Tuesday said it received a subpoena from the U.S. Department of Justice demanding information related to its key drug Actimmune, which is designed to spur the immune system.
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The initiative is part of an effort to ferret out unpublished research consucted by pharmaceutical companies that finds medications to be ineffective or dangerous.