This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more
In a 9-0 decision written by Justice Clarence Thomas, the US Supreme Court affirmed the decision by the US Court of Appeals for the Federal Circuit in Alice Corp. Pty. Ltd. v. CLS Bank Int'l, Case No.13-298, holding that all...more