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By Ropes & Gray LLP's FDA Regulatory Practice, Ropes & Gray LLP's Digital Health Practice Group
As such, the software output would be subject to FDA's regulations for FDA required labeling or promotional labeling, as applicable.
By Ama Adams, Brendan Hanifin, Emerson Siegle
The Société Générale settlement illustrates that U.S. sanctions enforcement is alive and well, despite below average enforcement activity year to date.
By Scott A. McKeown
For those seeking Patent Trial & Appeal Board (PTAB) related CLE/programming this month, the PTAB itself is hosting a Boardside Chat webinar this Thursday,
By Ropes & Gray LLP's Securities & Public Companies Practice, Ropes & Gray LLP's Executive Compensation & Employee Benefits Practice
Institutional Shareholder Services Inc. (ISS) and Glass, Lewis & Co. (Glass Lewis) have both released updates to their proxy voting guidelines
By Ryan Rohlfsen, Patrick J. Reinikainen, Christopher Nienhaus
On November 29, 2018, Deputy Attorney General Rod J. Rosenstein delivered remarks at the American Conference Institute's 35th International Conference on the Foreign Corrupt Practices Act.
By Scott A. McKeown
Efficiency Considerations Determined at the Time of Institution
By Kat Saunders Gregor
Hi, I'm Kat Gregor, and I am a tax partner in Ropes and Gray's Boston office.
By Ropes & Gray LLP's Health Care Practice
On November 15, 2018, the U.S. FDA published a proposed rule1 that would allow IRBs to waive or alter informed consent when a clinical investigation poses no more than minimal risk to, and includes appropriate safeguards...
By Isabelle Farrar, Kat Saunders Gregor
August 2018 brought two major developments in the Department of Treasury's race to finalize its partnership audit reform regulations before partnerships begin in early 2019 filing tax returns for the first time under the new regime.
By Michael Littenberg
Corporate social responsibility disclosure and compliance is an increasing area of focus for many in-house legal departments.
By Scott A. McKeown
In deciding the meaning of this term the Court reviewed the record of earlier concluded IPR proceedings.
By Ropes & Gray LLP's Health Care Practice
On November 21 and 23, 2018, the Centers for Medicare & Medicaid Services ("CMS") finalized rules reinforcing a developing trend away from delivery of care in traditional inpatient care settings.
By Ropes & Gray LLP's Health Care Practice
On November 1, 2018, the CMS released a proposed rule, available here, that updates requirements of the MA program, also known as Medicare Part C, and the Medicare Prescription drug benefit program.
By Ropes & Gray LLP's Health Care Practice
On November 2, 2018, the Health Resources and Services Administration of the United States Department of Health and Human Services
By Ropes & Gray LLP's Health Care Practice
These final rules, released for prepublication display on November 1 and 2, reinforce a developing trend away from delivery of care in traditional inpatient care settings.
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