Agency expands enforcement discretion, focusing its oversight on a discrete subset of mobile apps that present the greatest risk to patients.
On September 23, the U.S. Food and Drug Administration (FDA or the Agency)...more
On July 9, 2013, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Medical Device Reporting for Manufacturers (hereinafter “Draft Guidance”). FDA has not updated its formal...more
This entry updates our entry of April 9, 2013 and this corresponding Osler Update by Andrew Herr regarding the Final Guidance on Leveraged Lending.