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Focus on Regulation

Tag Archives: Affordable Care Act

Sample Reporting Under Section 6004 of the Affordable Care Act

We’ve received a number of questions lately about the status of the sample reporting requirements under Section 6004 of the Affordable Care Act (ACA) of 2010.  Section 6004 requires that manufacturers and authorized distributors submit certain information about drug sample distribution to FDA: (1) the identity and quantity of drug samples requested; (2) the identity

Review of issues for 2013

The following is a summary of some of the key issues Congress and the Administration will be debating in 2013. Please contact us with any questions. We are happy to provide further analysis as well as insight into other areas of interest. Agriculture: Tom Vilsack is expected to stay on as Secretary of Agriculture. The

Breaking decisions from the Supreme Court: Term in review

On Tuesday afternoon, three of Hogan Lovells’ Appellate practice partners will provide an analysis of some of the key decisions that will impact businesses as the Supreme Court concludes its current term. Neal Katyal, former Acting Solicitor General of the United States and Appellate practice Co-Director, Cate Stetson, Co-Director of our Appellate practice; and Chris