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
The United States Environmental Protection Agency (“EPA”) issued a direct final rule on August 9th denominated: Hazardous Waste Generator Improvements Rule, the Hazardous Waste Pharmaceuticals Rule, and the Definition of...more
California’s Pharmaceutical and Sharps Waste Stewardship Act requires pharmaceutical companies doing business in the state to develop and submit a “stewardship plan” to CalRecycle, a branch of the state’s Environmental...more
On September 30, 2020, the Washington State Department of Ecology (Ecology) adopted updates to its Dangerous Waste Regulations, Chapter 173-303 WAC. These updates go into effect on October 31, 2020. The updated...more
Legislative Day 38 — June 24, 2020 - With only two legislative days remaining in the 2020 Legislative Session, floor activity in the House and Senate hit a fever pitch as legislators jockeyed to get their measures amended,...more
While health care providers, including long-term care providers, rightly have been consumed the past several months with preparing for and responding to the novel coronavirus pandemic, regulatory agencies across the United...more
The United States Environmental Agency (“EPA”) released December 19, 2019 interpretive guidance titled: Manifesting Non-Creditable Hazardous Waste Pharmaceuticals – New Four Character Code (“Guidance”) - The document...more
The U.S. Environmental Protection Agency’s final rule governing management of hazardous waste pharmaceuticals became effective August 21, 2019. The new regulations apply to the management of hazardous waste pharmaceuticals by...more
On August 21, 2019, EPA’s Final Management Standards for Hazardous Waste Pharmaceuticals takes effect federally. The sewer ban component of the new rule applies in all states....more
The Washington Department of Ecology is planning several amendments to state dangerous waste regulations. The agency’s preproposal statement of inquiry released on August 2, 2019, indicates that the amendments would...more
Earlier this year, the Environment Protection Agency (“EPA”) adopted a final rule imposing new standards for the management of hazardous waste pharmaceuticals (“HWPs”) that goes into effect on August 21, 2019 (“Final Rule”)....more
The United States Environmental Protection Agency (EPA) recently issued its Final Rule imposing new requirements for hazardous waste pharmaceuticals. The Hazardous Waste Pharmaceuticals Rule, issued February 22, 2019,...more
I undertook a presentation on April 17th at the Arkansas Environmental Federation Regulated Waste Seminar titled: Solid and Hazardous Waste Judicial/Regulatory Developments: 2018 – 2019 - The discussion addressed...more
On February 22, 2019, EPA published its final rule governing standards for the management of pharmaceutical hazardous wastes in the Federal Register (Final Rule). The Final Rule’s publication in the Federal Register sets...more
The U.S. Environmental Protection Agency (“EPA”) recently issued new regulations for managing pharmaceutical waste under the Resource Conservation and Recovery Act (“RCRA”). The rules specify new requirements for hazardous...more
On December 11, 2018, the Acting Administrator of the U.S. Environmental Protection Agency (EPA or "the Agency”) signed a final rule establishing special management standards for pharmaceutical wastes that are classified as...more
The U.S. Environmental Protection Agency (“EPA”) has finalized the long-awaited rule — Management Standards for Hazardous Waste Pharmaceuticals and Amendment to the P075 Listing for Nicotine (“Final Rule”)....more
Our Environment, Land Use & Natural Resources and Food, Drug & Device/FDA Groups explain how the EPA’s final rule on how to dispose of hazardous waste pharmaceuticals will affect health care facilities, reverse distributors,...more
While much of the environmental bar was focused on the Waters of the U.S. rulemaking, on December 11, U.S. EPA Acting Administrator Andrew Wheeler signed the new hazardous waste pharmaceutical rule. The final rule retains a...more
The United States Environmental Protection Agency (“EPA”) and Gastroenterology Consultants of San Antonio, P.A. (“GCS”) entered into a Consent Agreement and Final Order (“CA”) addressing alleged Resource Conservation and...more
Regulatory reform has dominated the Trump administration’s environmental policy agenda to date, fueled by Executive Orders requiring agencies to identify unnecessary regulations for revision or outright rescission, and to...more
A pre-publication draft of a proposed rule by EPA may clarify hazardous waste requirements for obsolete or defective pharmaceuticals. EPA proposes a new Subpart P entitled “Hazardous Waste Pharmaceuticals” to 40 CFR Part 266...more
On August 31, 2015, EPA released two proposed hazardous waste rules under the Resource Conservation and Recovery Act (RCRA) that will be soon be available for public comment after they are published in the Federal Register....more