
We are pleased to welcome attorney Nadine Peters to our nationally-recognized Health Care Group. Nadine comes to Verrill Dana with more than 15 years of experience as a health care and privacy attorney and focuses on clients within the health
Research law is what Verrill Dana's Academic and Clinical Research Group does, and this blog is where the Group shares its musings and breaking news alerts in the research arena. If your days involve digesting and implementing the complex regulatory framework that governs the conduct of research, and grappling with underlying ethical considerations, this blog will serve as a helpful resource.
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal “Right to Try”
As discussed in our Alert of June 4, “Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now, manufacturers, patients, providers…
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (S. 204), which had passed…
In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“IFR…
On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate…
As many of you know, most of the provisions of the Final Rule updating the Common Rule (“2018 Common Rule”) will go into effect, and compliance is required, on January 19, 2018. Notwithstanding some uncertainty with respect to…
Portions of Kate Gallin Heffernan’s presentation at the American Health Lawyers Association conference on legal issues affecting academic medical centers and teaching institutions were quoted in a March 15, 2017 Bloomberg Law: Medical Research Law & Policy Report article entitled…
January 24, 2017 5:05 pm
As many of you know, the long-awaited final rule updating the Common Rule (“Final Rule”) was issued officially January 19 (after an unofficial release to the public yesterday). Like many of you, we are in…
Whether or not you agree with its position, there is no denying that in its recently released report, “Dead on Arrival,” the Goldwater Institute takes a passionate stance on the current status of the federal “Compassionate Use” program and its…