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CCH NetNews™ |
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(October 6, 2009)
Food and Drug Law |
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Manufacturers would be provided clear guidelines on adherence to current good manufacturing practices (cGMP) for each component of combination products under a FDA proposal. The proposal would clarify which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product under a streamlined regulatory framework. Under the proposal, manufacturers would be permitted to achieve compliance with the cGMP requirements in a co-packaged or single entity combination product either by: (1) demonstrating compliance with the specific cGMP regulations of each constituent part included in the combination product or (2) demonstrating compliance with the drug cGMPs, rather than both, when the combination product contains a drug and a device. FDA Proposal.
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Artificial or natural flavors, other than tobacco or menthol, may not be a constituent or additive in cigarettes according to a special rule established by the FDA. Herbs or spices, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee will also not be permitted as a characterizing flavor of the cigarette product or cigarette smoke. Pursuant to the “Family Smoking Prevention and Tobacco Control Act,” (Public Law 111-31, ¶2006) cigarettes failing to comply with the requirements will be subject to seizure; manufacturers, distributors, and retailers may also be subject to civil money penalties or criminal prosecution. FDA Notice.
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Five new drug applications (NDAs) are subject to having their approval withdrawn by the FDA because the sponsors failed to file required annual reports for the applications. The failure of an applicant to file a timely written notice of participation and request for a hearing constitutes a waiver of contentions concerning the legal status of the drug products. The products involved affected by the FDA's actions are applications held by Schmid Laboratories, Inc., Merck & Co., Inc., Arnar-Stone Laboratories, Inc., and A.R. Winarick, Inc. FDA Notice.
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A grant was awarded to the Georgetown University Lombardi Cancer Research Center and Department of Oncology for a study on the extent of exposure to endocrine disruptors early in life increase later susceptibility to developing breast cancer by inducing heritable epigenetic changes in transcription factors, which are linked to increased breast cancer risk. The study titled “Genome Wide Methylation Arrays for Detection Markers of Increased Susceptibility to Mammary Cancer Caused by In-Utero Exposures to Endocrine Disruptors (U01)” will expose pregnant rodents to estrogen and estrogen-like endocrine disruptors at doses previously found to increase mammary cancer among offspring. FDA Notice.
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