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Author: Brenda Fulmer

FDA Adverse-Event Reports Go Public

01/17/2017
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Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable report to be updated quarterly. The data currently spans twelve years. Advocacy Groups Find Adverse-Event Reports Helpful for Protecting Consumers Business leaders, […]

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Homeopathic Teething Products Linked to Child Deaths, FDA Says

10/18/2016
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Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly nightshade, which it received due to its poisonous nature. Still, the plant has been used medicinally for five centuries. Food & […]

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Is Sponsor-Submitted Clinical Data Safe?

05/31/2016
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Is Sponsor-Submitted Clinical Data Safe? The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication […]

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USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

05/23/2016
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A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug Administration or its overseas counterpart, the European Medicines Agency. Researchers compared adverse drug-reaction data for anticonvulsants […]

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