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CCH NetNews™ |
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(October 27, 2009)
Food and Drug Law |
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The FDA reopened until October 19, 2010, the comment period of a public meeting held on May 27 and 28, 2009, to solicit input on developing Risk Evaluation and Mitigation Strategies (REMS) for certain opioid drugs. The affected opioid drugs included long acting and extended release brand name and generic products that were formulated with the following active ingredients: fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone. The FDA reopened the comment period in light of continued public interest in the topic and to provide an opportunity for all interested parties to provide information and share views on the matter. Interested persons were originally given until June 30, 2009, to comment. FDA Notice.
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A guidance to help applicants and the review staff in the FDA's Center for Drug Evaluation and Research determine when a drug belongs to an established pharmacologic class, as well as how to select the appropriate word, phrase, or term that describes the pharmacologic class for inclusion in approved prescription drug labeling was issued by the FDA. Titled “Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information,” the guidance applies only to the use of the pharmacologic class in the Indications and Usage section of Highlights of Prescribing Information labels. The guidance finalizes a draft document of the same title announced in the Federal Register of May 16, 2007. FDA Notice.
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The FDA should seek authority from Congress to augment the agency’s ability to identify foreign firms with a unique identifier to improve the safety of imported foods, as well as assess civil penalties, according to a Government Accountability Office (GAO) report. Although the Department of Homeland Security's Customs and Border Protection (CBP) is undertaking efforts to provide information about imported foods to the FDA for air and truck shipments, substantial gaps in enforcement and collaboration still exist because the agencies' computer systems do not communicate with each other when imported food shipments arrive at U.S. ports. The lack of communication may potentially increase the risk that unsafe food could enter U.S. commerce without FDA review, particularly at truck ports. The GAO report also detailed the FDA's limited authority to ensure importers’ compliance with its regulations, because both the CBP and the FDA do not identify importers with a unique number. GAO Report.
On October 13, 2009, the FDA warned four companies to stop marketing unapproved codeine sulfate tablets. The drugs are opioid analgesics, commonly called narcotics, that are used to treat pain. The products never received FDA approval and the agency had no evidence that they were safe and effective. The manufacturers and distributors that received the warning letters for manufacturing and distributing codeine sulfate tablets, 30 mg and 60 mg are: (1) Lehigh Valley Technologies Inc., Allentown, Penn; (2) Cerovene Inc., Valley Cottage, N.Y. (3) Dava International Inc., Fort Lee, N.J. and (4) Glenmark Generics Inc. USA, Mahwah, N.J. Manufacturers have 90 days to cease manufacturing of new product and distributors have 180 days to cease further shipment of existing products. FDA News Release.
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