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Investigations Prescription Drugs

Gardner Law

Nevada Filing Deadlines Are Approaching: What Manufacturers Need to Know

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Drug and device manufacturers doing business in Nevada have upcoming filing deadlines in March, April, and June. By June 1, 2024, compliance officers must sign and submit a certification to the Nevada Board of Pharmacy to...more

Health Care Compliance Association (HCCA)

Privacy Briefs: December 2023

Report on Patient Privacy 23, no. 12  (December, 2023) Northwell Health in New York and Cook County Health in Chicago each experienced impacts from a breach at Nevada-based transcription company Perry Johnson & Associates...more

Foley & Lardner LLP

FDA Encourages the Use of Decentralized Clinical Trials in New Draft Guidance

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On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

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Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

White & Case LLP

Five Drug Pricing Issues to Watch in 2023

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Despite a busy 2022, drug pricing remains a hot topic at the federal and state levels, with a number of recent developments and trends worth monitoring heading into 2023. In the past year, the FTC increasingly focused on the...more

Verrill

Maine, New Hampshire, & Vermont Remain DOJ Health Care Enforcement Priorities: Targeted Federal Enforcement Presents Serious Risk

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The United States Department of Justice (DOJ) has recently emphasized that Maine, New Hampshire, and Vermont are priorities for health care investigations and anticipated significant enforcement. Even well-managed (and...more

Sheppard Mullin Richter & Hampton LLP

Maneuvers on the 340B Drug Pricing Program Battlefield: Duplicate Discounts and Contract Pharmacies

In a December 12, 2017 Advisory Board article, “The 340B drug pricing controversy, explained,” Scott Orwig wrote, “the 340B Drug Pricing Program is one of the most contentious issues in health care: Its critics say it ‘hurts...more

Hogan Lovells

FDA updates industry on what drug & biologic inspections will occur during COVID-19 pandemic

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On Wednesday, August 19, the U.S. Food and Drug Administration (FDA) issued guidance providing some additional insight into how the agency will determine what drug and biologic inspections may take place during the COVID-19...more

ArentFox Schiff

Investigations Newsletter: Health Information Technology Developer to Pay $145 Million to Resolve Kickback Allegations

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In the DOJ’s first-ever criminal action against an electronic health records vendor, San Francisco-based Practice Fusion Inc. agreed to pay $145 million to resolve allegations that it received kickbacks from pharmaceutical...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

Nossaman LLP

Death Certificate Project: A Dragnet!

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The Medical Board of California (“MBC”) began this project in 2013 when it required coroners to inform it of deaths resulting from opioids.  The influx of coroners’ reports triggered an intense enforcement effort by the MBC...more

Bradley Arant Boult Cummings LLP

'Opioids and Legal Enforcement — A Primer' - HarrisMartin's Drugs & Medical Devices

The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more

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