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August 15, 2013 | |||||||||||
Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC office, and articles from members of AGG outside the Food and Drug Practice. In this Issue
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Industry Insights | |||||||||||
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Pharmaceuticals One Thing Leads to Another: FDA Enforcement in One Area Bleeds into a Second Wyeth Pharmaceuticals Will Pay $490.9 Million for Marketing the Prescription Drug Rapamune for Unapproved Uses On July 30, 2013, the Justice Department and the Department of Health and Human Services Office of the Inspector General announced that Wyeth Pharmaceuticals Inc. will pay $490.9 million to settle criminal and civil claims arising from the unlawful marketing of the prescription drug Rapamune. In 1999, Wyeth received approval from the Food and Drug Administration to market Rapamune, an immunosuppressive drug that prevents the body’s immune system from rejecting a transplanted organ, for use in renal (kidney) transplant patients. The criminal and civil settlements each address Wyeth’s promotion of the drug for unapproved use in non-renal transplant patients. More > Bad Data In, Bad Data Out? FDA Issues a Warning Letter Against a Clinical Trial Investigator In June 2013, the Food and Drug Administration (FDA) issued a Warning Letter to a clinical trial investigator for not complying with applicable requirements governing clinical investigations and the protection of human subjects. The Warning Letter serves as a reminder of FDA’s enforcement authority and a wake-up call to sponsors that rely on investigators to conduct studies that may be used to support marketing applications.More > |
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Medical Devices FDA Draft Guidance Clarifies Medical Device Reporting for Manufacturers |
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Food Senate Committee Scrutinizes Energy Drink Marketing to Youth and Social Media Tactics |
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AGG Attorneys Co-Author Book Chapter on FDA Inspection and Enforcement William H. Kitchens and Alan G. Minsk co-authored a book chapter entitled "FDA Inspection and Enforcement" for Fundamentals of U.S. Regulatory Affairs (Eighth Edition), published by the Regulatory Affairs Professionals Society. The book is well-suited to professionals new to U.S. regulatory affairs or those looking for a reference on FDA regulatory requirements, processes, and policies. It is used as a training tool at many prominent healthcare organizations and universities. More > William Kitchens Enters 34th Year of Teaching at Emory University School of Law William H. Kitchens, who advises companies in the food, medical device, pharmaceutical and biotech industries, began serving as an adjunct professor at Emory University’s School of Law in 1979. August 20 marks his 34th year of teaching food and drug law. | |||||||||||
Upcoming Events | |||||||||||
This newsletter is published by Arnall Golden Gregory’s Food and Drug and Government Affairs and Public Policy Practices. This information presented provides a general summary of recent legal and regulatory developments. It is not intended to be, and should not be relied upon, as legal advice. For more information about the Food and Drug Practice, please contact Alan Minsk.
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