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Fourth Circuit Clarifies Scope of Federal Preemption for Requirements Governing Medical Devices
The United States Court of Appeals for the Fourth Circuit recently affirmed a West Virginia federal district court's holding that a plaintiff's common law tort claim was preempted by the 1976 Medical Device Amendments…
USDA Publishes Two Proposed Rules Regarding Ingredients in Organic Food Products
Today the United States Department of Agriculture's (USDA) Agricultural Marketing Service (AMS) published two proposed regulations that will affect companies that produce and market organic food products. One proposed…
FDA Expands Scope of Reporting for Discontinued Drugs
The FDA has published an interim final rule amending definitions related to required notifications regarding drug shortages. 21 C.F.R. 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer certain…
Health and Human Services Inspector General Report Identifies Shortcomings in FDA Oversight of State Food Inspections
On December 14, 2011, the Inspector General of the Department of Health and Human Services issued a report finding that the Food and Drug Administration (FDA) failed to properly oversee food facility inspections…
FDA makes "Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review" available for comment
On December 13, 2011, FDA announced the availability of a draft report entitled “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” for public comment. The literature review was…