FDA Proposes Withdrawal of Low Blood Pressure Drug
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- Category: FDA
The U.S. Food and Drug Administration proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.
EMA and US FDA seek potential candidate companies for joint GMP inspection programme
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- Category: EMA
The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products.
European Medicines Agency starts review of rosiglitazone-containing medicines
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- Category: EMA
The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile.
FDA to Communicate Safety Monitoring Activities to Consumers and Health Care Professionals
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- Category: FDA
The U.S. Food and Drug Administration unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.
FDA: Rare Cases of Liver Injury Reported with Use of Xenical, Alli
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- Category: FDA
The U.S. Food and Drug Administration advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.
FDA Announces Collaboration with Drugs.com
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- Category: FDA
The U.S. Food and Drug Administration announced today that it will collaborate with the Web site Drugs.com to expand access to the FDA's consumer health information. Drugs.com seeks to provide patients with information to better manage their own health care and to assist in the reduction of medication errors.
'Bad Ad Program' to Help Health Care Providers Detect, Report Misleading Drug Ads
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- Category: FDA
The U.S. Food and Drug Administration launched a program designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.
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