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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…
Bioethics Commission Study Released
The Presidential Commission for the Study of Bioethical Issues has released its report “ Moral Science: Protecting Participants in Human Subjects Research .” The report was requested by President Obama to determine if…
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…
FSIS Delays Effective Date of New Meat Labeling Regulations
Responding to a letter from eight trade associations asking for more time to prepare for compliance, the Food Safety and Inspection Service (FSIS), an agency within the Department of Agriculture, has decided to delay…