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
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
The FDA is requesting public comments on a possible change to the Opioid Analgesic Risk Evaluation and Mitigation Strategy requiring opioid analgesics (OA) used in an outpatient setting to be dispensed with mail-back...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
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
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
On December 11, 2018, U.S. EPA Acting Administrator Andrew Wheeler signed a new hazardous waste pharmaceutical rule. The final rule retains a proposed requirement, opposed by industry, that prescription pharmaceuticals sent...more
Barnes Johnson, Director of the United States Environmental Protection Agency (“EPA”) Office of Resource Conservation and Recovery (“RCRA”) authored a September 11th memorandum titled: Management of Household...more
The California Senate enacted Senate Bill 212 (SB 212) which would create a statewide drug and needle take-back program. SB 212 would require entities that sell drugs or sharps in the state of California to individually...more
Governor Cuomo signed into law on Tuesday, July 10, 2018 the New York State Drug Take Back Act (“Act”). New York joins the State of Washington as the first two states to adopt statewide drug take back programs for unwanted...more
On March 22, 2018, the Governor of the State of Washington signed the Secure Drug Take-Back Act, which establishes the first statewide drug take-back program in the nation. The Act requires manufacturers of “covered drugs”...more
The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more
The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more
Questions remain about the U.S. Drug enforcement agency’s rules on secure disposal of controlled substances and exactly how they will be implemented with regard to the disposal of controlled substances by hospice personnel...more
On September 30, 2014, the Ninth Circuit affirmed the Northern District of California’s summary judgment that the Alameda Safe Drug Disposal Ordinance (the “Ordinance”) does not violate the dormant Commerce Clause of the...more