The Ins and Outs of Medical Treatment in New Jersey Workers' Compensation Claims
The Presumption of Innocence Podcast: Episode 22 - Reclaiming Purpose: A Transformative Journey Through Addiction, Rehab and Prison
Taking the Pulse, A Health Care and Life Sciences Podcast | Episode 105: Sara Goldsby, Director, DAODAS
DE Under 3: Vaccine Mandate Updates, Contractor Unique Entity Identifiers, EEOC Nominations & A Reduced VEVRAA Hiring Benchmark
Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act
Healthcare Headlines Episode 3 - Stay Ready: Trends in Healthcare False Claims Act Investigations
Workers' Compensation Academy: New Jersey Workers' Comp: Medical Marijuana and Opiates
Jones Day Talks Health Care: The Eliminating Kickbacks in Recovery Act
This Week in FCPA-Episode 77, the Home for the Holidays Edition
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
On July 10, the Centers for Medicare & Medicaid Services (CMS) released the Medicare Physician Fee Schedule Proposed Rule (Proposed Rule) for the calendar year 2025. The Proposed Rule would implement certain provisions of the...more
Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more
At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency during the impending year, especially...more
It is well known that opioid overdoses have occurred at epidemic levels in the United States for years. According to the U.S. Centers for Disease Control and Prevention (CDC), opioid overdose deaths have increased from 21,089...more
BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more
There is a critical need to increase access to evidence-based care for justice-involved pregnant people with a substance use disorder (SUD)—and connect them to continued coverage and care upon release—according to national...more
Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more
The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD). According to the FDA’s press release,...more
This report was written in partnership with and funded by the Foundation for Opioid Response Efforts. During the COVID-19 pandemic, the federal government and many states offered regulatory flexibilities intended to make...more
Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •FTC and FDA Weed Out Misleadingly Marketed THC-Containing...more
13 Republican AGs wrote a letter to the FDA in response to its Request for Information regarding “In-Home Disposal Systems for Opioid Analgesics,” a proposed mail-back program for leftover opioid products....more
On May 9, 2023, the U.S. Food and Drug Administration (FDA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a joint statement regarding both agencies’ commitment to providing evidence-based...more
TikTok Ban - The Senate State and Local Government Committee this week passed S 83, a bill that would prohibit use of “high risk platforms” (including websites and applications) on public devices and networks. It lists...more
Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...more
The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...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
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On February 10, in Adapt Pharma Operations Ltd. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit affirmed a district court’s holding that Adapt’s methods of treatment of opioid overdose is invalid as obvious. The...more
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more
In August 2018, the Province of British Columbia (Province) commenced a class action on behalf of itself and other provincial and federal governments against approximately 50 pharmaceutical manufacturers, wholesalers, and...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
FDLI hosted a virtual conference December 9–10, 2021. The keynote address was given by Arun Rao, Deputy Assistant Attorney General at the United States Department of Justice (DOJ). Arun Rao discussed the efforts of the...more