Ad Law Access
The "Prior Substantiation" Doctrine: An Important Check On the Piggyback Class Action
A disturbing trend has emerged in false advertising litigation: plaintiffs are filing class action complaints that are virtually identical to or rely heavily on FTC complaints or FDA warning letters. Those complaints…
Food Safety Working Group Releases 2009-2011 Progress Report
The Federal Food Safety Working Group (“FSWG”) yesterday released a progress report highlighting the groups accomplishments over the last two years and outlining priorities for the future. Established by President…
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…