Drugs

Homeopathic Drug Regulation Sought

The Americans for Homeopathy Choice Foundation is asking FDA to issue a proposed regulation drafted by the foundation on “Homeopathic Drugs and Drugs Labeled ‘Homeopathic.’” The 6/5 petition says the foundation wants FDA to establish regulations that assure consumers that drug products labeled homeopathic are either included in the Homeopathic Pharmacopoeia of the United States (HPUS) or can be reasonably expected to be accepted for inclusion in the HPUS because they meet eligibility thresholds, as determined by relevant third-party review.

The regulation also would provide that products that do not meet the criteria drafted by the foundation could not be labeled homeopathic, that homeopathic drugs are not adulterated and are properly labeled, and that FDA applies standards acceptable for low-risk products when evaluating the risks of homeopathic drugs.

The proposal further asks that the agency recognize that “homeopathic drugs, properly manufactured and labeled, and evaluated by appropriate standards, do not meet the legal definition of ‘new drugs’ and therefore are not subject to premarket review other than satisfying the requirements of current or likely inclusion in the HPUS.”

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome