On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written
21st Century Cures
The Future of Research Using Electronic Medical Records Data: Precision Medicine Initiative Privacy and Trust Guiding Principles Provide Another Piece of the Puzzle
By Amy K. Dow on
Posted in Privacy and Security Law
One thing’s certain – the vast and growing supply of data contained in electronic medical records systems will play a significant role in improving the speed and efficiency of research into new treatments in the years to come. The challenge will be striking an appropriate balance between the unquestionable promise of this data to enable…
House Energy and Commerce Committee Proposes, then Drops, 340B Reform Language to 21st Century Cures Legislation
By Alan J. Arville, Constance A. Wilkinson and Selena M. Brady
The House of Representatives Energy and Commerce Committee (“the Committee”) circulated draft language to include in its 21st Century Cures legislation earlier this week to reform the 340B drug discount program (the “340B Program”). Although the draft 340B language was pulled from…