False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more
This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...more
Among other things, on May 19, 2023, the U.S. Department of Commerce’s Bureau of Industry and Security (“BIS”) issued a sweeping new set of restrictions that collectively operate to deter the Putin Regime from acquiring...more
China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more
This regular update (no. 98 | 1 March 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
This regular update (no. 95 | 9 January 2023) covers key regulatory EU developments related to the evolving COVID-19 situation (Antitrust & State Aid; Trade/Export Controls; Medicines, Medical Devices and Personal Protective...more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion....more
This regular alert covers key regulatory EU developments related to the COVID-19 situation. It does not purport to provide an exhaustive overview of developments and contains no analysis or opinion. ...more
COMPETITION & STATE AID - State Aid - European Commission adopts Temporary Crisis Framework to support economy in context of Russia's invasion of Ukraine - On 23 March 2022, the Commission adopted a Communication on a...more
COMPETITION & STATE AID - State Aid - European Commission publishes first Report on implementation of Recovery and Resilience Facility - On 1 March 2022, the Commission published its first Report to the European...more
COMPETITION & STATE AID - Competition - Commission publishes Competition Policy – 2021 at a glance. On 22 December 2021, the European Commission published its Competition Policy – 2021 at a glance. ...more
COMPETITION & STATE AID - Competition- European Commission expresses views on IAG’s (aborted) intended acquisition of Air Europa, including in light of impact of COVID-19 restrictions - On 16 December 2021, the...more
COMPETITION & STATE AID - Competition - Executive Vice President and Competition Commissioner Margrethe Vestager speaks at U.S. Chamber of Commerce's Transatlantic Business Works Summit. ...more
COMPETITION & STATE AID - State Aid - European Commission adopts revised Guidelines on State aid to promote risk finance investments- On 6 December 2021, the Commission published its Communication on Guidelines on...more
COMPETITION & STATE AID - State Aid - European Commission publishes revised Communication on State aid rules for Important Projects of Common European Interest (IPCEI). On 25 November 2021, the Commission published a...more
COMPETION & STATE AID - European Commission adopts Communication on a Competition Policy Fit for New Challenges - On 18 November 2021, the European Commission adopted a Communication on a Competition Policy Fit for New...more
COMPETITION & STATE AID - European Commission comments on transatlantic relations in post-pandemic world, including building resilient supply chains - On 12 November 2021, Executive Vice-President and Competition...more
On July 27, Reps. John Joyce (R-PA) and Jim Banks (R-IN) introduced legislation that would establish new US trade negotiating objectives for the pharmaceutical sector, in the context of a broader renewal of the trade...more
In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...more
Now that it appears Joseph R. Biden Jr. has won the presidency, it’s time to take a serious look at the Democratic Party platform and how a Biden administration will likely impact business....more
Report on Research Compliance 17, no. 7 (July 2020) - NIH has opened its “initial data set and tools” in its All of Us research program to investigators under a new beta model that does not allow downloading of...more
The COVID-19 pandemic is significantly disrupting international trade as global and domestic supply chains grapple with declining trade volumes and inadequate supplies of medical goods, including personal protective equipment...more
On 17 April the Federal Emergency Management Agency (FEMA) released significant exceptions (effective Friday 17 April, but to be published on 21 April) to FEMA's temporary final rule prohibiting exports of certain personal...more
In an Alert published on April 10, we discussed temporary restrictions that the Federal Emergency Management Agency (FEMA) had placed on the export from the United States of certain personal protective equipment (PPE). ...more
On April 10, 2020, the U.S. Federal Emergency Management Agency (FEMA) published a Temporary Final Rule as part of its response to the COVID-19 pandemic. The Temporary Final Rule allocates certain scarce or threatened...more