FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation. 17, 2020.

Management 52

Management Manufacturing Specialization IT 52

FDA Law

MAY 7, 2025

Two recent cases from the Fifth and Seventh Circuits, however, support the legality of these arrangements in the absence of the government proving certain circumstances. Medicare or Medicaid). OIG reviews non-safe harbored arrangements on a case-by-case basis. In contrast to its decision in United States v. Polin , 194 F.3d 3d 863 (7th Cir.

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

DECEMBER 7, 2023

There were too many interesting panels and discussions to mention them all, but presentations about DOJ’s and FDA’s coordination deserve some special mention. Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week.

Consulting 52

Consulting Manufacturing Provider Specialization 52

FDA Law

JUNE 7, 2023

The cases were both brought under the False Claims Act (FCA), the Civil War-era law that the government uses to claw back funds it pays out to parties that overbill federal programs. The FCA incentivizes whistleblowers to come forward by awarding them a cut of any recovery. What was SuperValu all about?

Government 40

Government Patient-Centered Manufacturing IT 40

FDA Law

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Incomplete and inaccurate records currently subject registrants to civil monetary penalties of up to $15,691 per violation. 17, 2020.

Management 40

Management Manufacturing Specialization IT 40

FDA Law

SEPTEMBER 30, 2022

The controversy over the FCA’s intent standard where the applicable statute or regulation is ambiguous has special relevance when the FCA is used to target inaccurate government price calculations. The relator has until December 22, 2022 to petition for certiorari to the Supreme Court. of America v.

Manufacturing 40

Manufacturing Insurance Specialization Government 40

FDA Law

MAY 11, 2023

government in the now-infamous (at least in FDA circles) Teva v. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.” GSK skinny label case , the U.S.

Government 72

Government Manufacturing IT Utilities 72

FDA Law

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

GeriPal

DECEMBER 7, 2023

Summary Transcript Summary To my teenagers, climate change is an existential crisis. It’s the end of the world as we know it. They decry the lack of serious attention and prioritization this issue has in the US. My kids ask – why don’t adults care about this issue the same way that they and their friends care about it? Ruth: Thank you.

Healthcare 129

Healthcare IT Education Community 129

Physician's Weekly

JULY 3, 2025

But the administration is seeking to cut government funding that could serve as a counterweight. The Trump administration has declared that it will aggressively combat chronic disease in America. The report denounces industry-funded research on chemicals and health as widespread and unreliable. Kennedy Jr.

Chronic Disease 52

Chronic Disease Government Engineering IT 52

FDA Law

MAY 23, 2025

During the first Trump Administration, the 10-for-1 Rule seemed to be more in name only when it came to FDA, whereas this administration seems more intent on its deregulatory approach, so we expect it to have more of an impact on FDA governance this time around. The Announcement raises several questions and issues for the device industry.

Manufacturing 59

Manufacturing Specialization IT Provider 59