News & Analysis as of

Clinical Trials Healthcare Reform

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Hogan Lovells on

Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

Manatt, Phelps & Phillips, LLP

[Webinar] Reimagining Medicine: Can Policy Keep Pace With Scientific Advances? - February 1st, 1:00 pm - 2:00 pm ET

Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share Insights on How Medical Innovation Is Disrupting Policy—and What Needs to Come...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

Butler Snow LLP on

From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report – Legislative Day 7 2022

It was Mental Health Day under the Gold Dome, headlined by the unveiling of Speaker David Ralston’s (R-Blue Ridge) much discussed, and anticipated, mental health parity bill. House lawmakers, members of the Behavioral Health...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

Hogan Lovells

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

Hogan Lovells on

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more

Manatt, Phelps & Phillips, LLP

Health Update - September 2015

Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more

Mintz - ML Strategies

Health Care Update - May 2015

Mintz - ML Strategies on

In This Issue: - House Energy and Commerce Continues 21st Century Cures Progress - Pioneer ACO Program to be Expanded - Federal Regulatory Initiatives - Congressional Initiatives - Other Health Care...more

Polsinelli

FDA Deputy Commissioner Details Agency’s Priorities In Recent Speech

Polsinelli on

In This Issue: - Snapshot of the Agency: FDA-regulated products - Recent Public Health Milestones - Innovative Programs at FDA ..A. FDA has a number of programs intended to speed the availability of...more

Snell & Wilmer

Agencies Provide Guidance on Additional Health Care Reform Changes Impacting Non-Grandfathered Employer Group Health Plans

Snell & Wilmer on

The Departments of Health and Human Services, Labor, and Treasury (collectively, the “Departments”) during the first half of the year issued guidance in the form of Frequently Asked Questions (the “FAQs”) on certain...more

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