FDA Tightens Restrictions on Accutane
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The US Food and Drug Administration announced Tuesday that it has set up a national registry to follow women of childbearing age who are prescribed the acne drug Accutane
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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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TORONTO, Jan. 6 -- The Canadian health minister plans to restrict the supply of inexpensive prescription drugs shipped to about 2 million patients in the United States each year, and industry officials here are saying President Bush is behind the move.
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Responding to continuing criticism about its warning policies, the Food and Drug Administration said Friday it will strengthen its system for reviewing the safety of drugs already on the market.
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The US Food and Drug Administration is considering further regulatory measures, including withdrawal from the market, of Pfizer&#39;s arthritis treatment Celebrex.
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The US Food and Drug Administration is supposed to be a vigilant industry watchdog that prevents harmful products from reaching America&#39;s kitchen tables and medicine chests.
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The maker of the acne medication Accutane ignored a company doctor&#39;s recommendation that people who take the controversial drug be monitored for signs of depression and that a warning to that effect be added to the drug&#39;s US label, USA Today reported
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The regulatory approval was also a boost for the embattled drugs sector. It was feared that, following a series of safety crises, the US Food and Drug Administration would get tougher on new drugs.
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For the first time, manufacturers of vitamins, herbal pills and other dietary supplements will have to test all of their products' ingredients. The Food and Drug Administration said Friday it is phasing in a new rule that is designed to address concerns that existing regulations allowed supplements onto the market that were contaminated or didn't contain ingredients claimed on the label.
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The US Food and Drug Administration (FDA) announced on Monday that Mifepristoneâs label will be changed to acknowledge that there are risks associated with any abortion, and that physicians prescribing the drug should instruct their patients to contact
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Dec. 6, 2004 -- The FDA announced stricter rules on record keeping by food importers and distributors Monday, just days after Health and Human Services Secretary Tommy G. Thompson warned of dangers to the US food supply from terrorists.
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Description: Faced with a series of major lapses in drug safety, the Food and Drug Administration announces new measures to rectify the situation.
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U.S. regulators said on Wednesday they would crack down on marketing of an unapproved injectable anti-gout drug which has been linked to 23 deaths.
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Doctors and their patients continue to face problems with a program designed to limit use of an acne medication that can cause birth defects if taken by pregnant women, a dermatology group said Monday.
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For the past four years, the Food and Drug Administration has taken a noticeably less aggressive approach toward policing drugs that cause harmful side effects, records
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Drugmaker Pfizer Inc. is in talks with regulators over a likely change to arthritis drug Bextra&#39;s label to carry a strict warning alerting doctors of the risk of a potentially deadly skin
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The Food and Drug Administration  said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.