In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to inspectional observations issued at...more
The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 following a drug current...more
On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The guidance is intended for foreign and domestic...more
The U.S. Food and Drug Administration (FDA) published a draft guidance—the first of its kind—consolidating its expectations for how drug manufacturers should respond to Form 483 inspectional observations. The guidance applies...more
On March 6, 2026, the Food and Drug Administration (“FDA” or “the Agency”) issued a draft guidance, “Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection.” The draft guidance articulates...more
On March 5, 2026, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a settlement with MMG Fusion, LLC (MMG). MMG is a Maryland software company that was the subject of a complaint...more
The Mississippi Commission on Environmental Quality (“MCEQ”) and BFI Waste Systems of Mississippi, LLC (“BFI”) entered into a January 12th Agreed Order (“AO”) addressing alleged violations of a solid waste permit. See Order...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“ADEQ”) issued a January 20th Notice of Violation (“NOV”) to Jefferson County Waste Tire Processing Facility (“Jefferson County”)...more
Unlock the keys to effective compliance auditing & monitoring - Take a deep dive into auditing and monitoring, an important two-pronged approach to compliance program assessment and a core component of an effective...more
The California Department of Health Care Services (DHCS) has embarked on a robust transformation of the Medi-Cal program aimed at improving healthcare quality, access, and equity for members. These priorities have been...more
For years, the government has been touting the importance of healthcare organizations having an “effective” healthcare compliance program. The U.S. Department of Justice (DOJ) has issued a 25-page document on what it expects...more
Anyone who’s ever felt the healing touch of a skilled physical therapist (PT) or benefitted from other rehab services knows that such providers can be worth their weight in gold, helping to restore basic functions like...more
On December 18, 2025, the Food and Drug Administration (FDA) released a final guidance entitled “Processes and Practices Applicable to Bioresearch Monitoring Inspections.” The guidance was issued to comply with the Food and...more
This year, the federal government has seen an unprecedented level of scrutiny aimed at cutting waste and inefficiencies. While trimming waste and striving for greater efficiency are admirable pursuits, it is important not to...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and City of Manila entered into an August 29th Consent Administrative Order (“CAO”) addressing alleged violations of a Clean Water...more
Today, we take a moment to recognize the vital role compliance officers play in keeping organizations running smoothly and ethically. Compliance work is not easy, and those who do it deserve our gratitude for navigating...more
Learn the keys to effective compliance auditing and monitoring - The auditing and monitoring process is critical to a compliance program’s success, in that it provides ongoing assessment of processes, procedures, and...more
Taylor Swift, the billionaire pop icon, is famous for sending her fans secret messages in just about everything she does or says. In fact, her recent appearance on New Heights, the Kelce brothers’ podcast, had fans...more
Report on Patient Privacy 25, no. 9 (September, 2025) - Covered entities (CEs) and business associates (BAs) might be forgiven if the most recent HHS Office for Civil Rights (OCR) HIPAA enforcement action evoked little more...more
The Arkansas Department of Energy and Environment - Division of Environmental Quality (“DEQ”) and Saline County Waterworks and Sanitary Sewer PFB/Saline County Waterworks and Sewer WWTP (“SCW”) entered into an April 30th...more
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) has announced another settlement for alleged violations of HIPAA. OCR investigated BayCare Health System, which serves central Florida, after a...more
In the past several weeks, the U.S. Department of Health and Human Services ("HHS"), Office for Civil Rights ("OCR") has announced settlements with three health care organizations — Comstar, LLC ("Comstar"); Guam Memorial...more
A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more
In a significant enforcement move, California’s consumer privacy regulator just ordered a national clothing retailer to pay a $345,178 fine to resolve alleged violations of the state’s privacy law. The California Privacy...more
The Arkansas Department of Energy and Environment – Division of Environmental Quality (“DEQ”) and Pinewood Wastewater, LLC (“Pinewood”) entered into an April 9th Consent Administrative Order (“CAO”) addressing alleged...more