FDA Law

FEBRUARY 13, 2025

The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA may request additional information during the review of the PCCP.

Manufacturing 71

Manufacturing Management Specialization Provider 71

ABIM

APRIL 24, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Dr. Johnson led a discussion with the Rheumatology Board on community practice in rheumatology to create a more inclusive understanding of its role and scope. The following is a summary report of the spring meeting.

Board-Certified 40

Board-Certified Board-Certified Physicians Community Government 40

FDA Law

FEBRUARY 27, 2025

The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers. How regulators will interpret and enforce its provisions may not become clear for some time.

Clinical Practice 88

Clinical Practice Clinic Government Management 88

FDA Law

SEPTEMBER 28, 2021

Richardson — On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. By Kalie E.

Vaccination 98

Vaccination Individual Government Provider 98

FDA Law

MAY 3, 2021

Maintaining complete and accurate records with direct, ongoing oversight by management reduces risk of internal employee pilferage and maximizes potential for early detection should diversion occur. We will discuss these actions in more detail in later blog.

Management 40

Management Manufacturing Specialization IT 40

FDA Law

MARCH 3, 2024

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Office of Management and Budget (OMB) can also specify other equipment or services to be subject to the Act’s prohibitions. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

Manufacturing 102

Manufacturing Government Consulting IT 102

FDA Law

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. FDA Law Blog is a conference media partner for this event.

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Private Practice Specialization Government Management 52

FDA Law

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. And, frankly, it is a useful tool to manage potential whistleblowers by addressing concerns before they mushroom. By John W.M.

Supply Chain 66

Supply Chain Management Manufacturing IT 66

FDA Law

DECEMBER 2, 2021

As we move out of the COVID-19 pandemic, come hear from your peers about how they are staying compliance- and inspection-ready as FDA ramps up inspections, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year. Learn more here.

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Government Management 52

FDA Law

JANUARY 28, 2024

This is to say nothing of the Administrative Procedure Act (APA) challenges the final rule may be vulnerable to, including whether the Agency manages to meet its obligations to fully respond to the more than 6,000 comments it received on the proposed rule by the breakneck April timeline the Agency is pursuing for publication of the final rule.

Government 64

Government Medical Management IT 64

FDA Law

DECEMBER 1, 2022

As we move out of the COVID-19 pandemic, come hear from your peers about how they are staying compliance and inspection ready as FDA ramps back up inspections, what companies need to do to plan for and manage enforcement risk, trends in criminal and civil litigation, and government priorities for the new year.

Relationship 52

Relationship Government Management 52

FDA Law

MARCH 9, 2023

Attorney’s Offices, and, importantly for readers of this blog, the Civil Division’s Consumer Protection Branch (CPB), will all consistently reward corporations that voluntarily disclose and remediate misconduct. That means that the Criminal Division, 94 U.S. Monaco said was national transparency and consistency.

Government 52

Government Provider IT Management 52

FDA Law

JANUARY 31, 2022

Complaint ¶ 38.) While injunctive enforcement tools have been statutorily available for years, they were first successfully dusted off in 2019 to assist the government in its efforts to stem the tide of inappropriate dispensing in the wake of the country’s opioid crisis (blogged about here ). 21 U.S.C. §

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Government IT Provider Healthcare 40

FDA Law

DECEMBER 11, 2024

Date: Wednesday, December 11, 2024 Time: 12:00 PM to 1:15 PM ESTfda Presenters: Alan Kirschenbaum , Director, HPM Jennifer Lospinoso, Managing Director, Riparian LLC Lynn Buhl, Managing Director, Riparian LLC Please click here to register. Once you register, youll receive instructions by email on how to access the webinar.

Manufacturing 59

Manufacturing Management Provider Government 59

FDA Law

DECEMBER 9, 2024

Date: Wednesday, December 11, 2024 Time: 12:00 PM to 1:15 PM EST Presenters: Alan Kirschenbaum , Director, HPM Jennifer Lospinoso, Managing Director, Riparian LLC Lynn Buhl, Managing Director, Riparian LLC Please click here to register. Once you register, youll receive instructions by email on how to access the webinar.

Manufacturing 59

Manufacturing Management Provider Government 59

FDA Law

APRIL 24, 2024

As of Monday, April 22, FDA appears to be one step closer to achieving that timing goal with Office of Management and Budget (OMB) having completed its review of the final rule (see here ). Of course, if a new administration takes over next year, the rule’s future would be questionable, even without congressional action.

IT 59

IT Government Community Management 59

FDA Law

APRIL 6, 2025

Andrew draws on his government experience investigating and prosecuting violations of the FDC Act, the Controlled Substances Act, the False Claims Act, and other federal healthcare laws to now represent clients facing those issues. We look forward to her development and future success here, said HPM Managing Director J.P. Ellison.

IT 59

IT Nurse Practitioner Patient-Centered Specialization 59

FDA Law

MARCH 3, 2024

On March 1, the Office of Management and Budget (OMB) received the draft final LDT rule for review ( here ). Given that Congress struggles to keep the government funded, it is far-fetched now to expect Congress to enact this complex legislation – especially since it has repeatedly failed to do so. That hasn’t happened yet.

Government 64

Government IT Management Provider 64

FDA Law

FEBRUARY 11, 2025

Webinar Details: Date: Tuesday, February 18, 2025 Time: 12:00 PM to 1:30 PM ET Presenters: Alan Kirschenbaum , Director, HPM Sophia Gaulkin , Associate, HPM Cynthia Hwang, General Manager, Riparian LLC Susan Dunne, Managing Director, Riparian LLC Please click here to register. We hope youll join us!

Manufacturing 59

Manufacturing Management Government 59

FDA Law

FEBRUARY 4, 2024

The joint press release counters that “this is not the answer,” and alleges that “establishing a duplicative system for the oversight of tests by expanding CLIA would create more government bureaucracy and inconsistencies.” There is great irony in the agencies’ professed concern for increasing bureaucracy.

Clinic 59

Clinic Management Medical IT 59

FDA Law

FEBRUARY 5, 2024

Her expertise includes preparation and maintenance of licensing documentation, communications with state boards and government agencies, conducting research, and the preparation of associated licensing documentation and applications. Sara is conveniently able to be a client’s one-stop point of contact for licensing needs.

Consulting 45

Consulting Manufacturing Government Provider 45

FDA Law

SEPTEMBER 1, 2021

But the scope of regulatory diligence and its application to post-acquisition activities has broader implications, namely whether the government will hold the Buyer responsible, either criminally , civilly , or administratively , for the regulatory issues it inherited through the acquisition.

IT 52

IT Government Healthcare Management 52

FDA Law

NOVEMBER 6, 2023

The excellent work of these and other professionals at HPM is why we’ve maintained a high level of client service for 43 years,” said JP Ellison, HPM’s managing director. Our knowledge of the laws and regulations governing drugs, medical devices, foods, dietary supplements, and cosmetics is unparalleled in breadth and depth.

Government 40

Government Provider Medical Management 40

FDA Law

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. The NPA requires “management” review of “any discrepancies discovered during an employee’s blind count when accessing controlled substances.”

Board-Certified 52

Board-Certified Provider Government Management 52

FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. S&G Labs alleged during the litigation that they are paid on a “per test” basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct “self-pay” by some individuals. EKRA is codified at 18 U.S.C. § Graves , 2021 U.S. LEXIS 29248, at *2-3 (D.

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law

OCTOBER 10, 2022

You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here. While the final guidance continues to borrow some IMDRF concepts, it no longer limits Non-Device CDS to software that informs clinical management (per the IMDRF guidelines).

Clinic 52

Clinic Medical Provider Patients 52

FDA Law

APRIL 23, 2021

The Supreme Court has handed down a decision in AMG Capital Management, LLC, et al. Almost twenty years ago, two of the writers of this blog addressed that question in a law review article published by the Food and Drug Law Institute: Jeffrey N. By Karin F.R. Moore & Jeffrey N. Gibbs & John R. Fleder & Michael S.

Government 40

Government IT Transportation Provider 40

FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. S&G Labs alleged during the litigation that they are paid on a “per test” basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct “self-pay” by some individuals. EKRA is codified at 18 U.S.C. § Graves , 2021 U.S. LEXIS 29248, at *2-3 (D.

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

FDA Law

MARCH 20, 2022

To clarify what preparations companies should take to more seamlessly manage a recall, on March 2, 2022, FDA published its Final Guidance Document on Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C.

Electronics 40

Electronics Manufacturing Provider IT 40

ABIM

JUNE 11, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Board-Certified 52

Board-Certified Government Community Education 52

ABIM

JUNE 4, 2025

Visit the ABIM Blog for reports of prior meetings. Community Practice in ABIM Governance* Erica N. She also sought input on overlapping aspects of community practice across the disciplines of internal medicine to inform ABIM’s recruitment efforts for broad physician representation in governance roles.

Diabetes 52

Diabetes Board-Certified Telehealth Government 52

FDA Law

MARCH 6, 2025

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. The DCP should follow applicable regulations governing human subject protections, where applicable.

Manufacturing 105

Manufacturing Management Clinical Practice Clinic 105

FDA Law

APRIL 8, 2024

What about government factors that cause drug shortages? pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), wholesale distributors) play before a finished product ever makes it to a patient. Section I.C Two such factors come to mind: FDA inspections and DEA quotas.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law

NOVEMBER 21, 2024

All DEA-registered practitioners may continue to prescribe via audio-visual telemedicine encounters schedule II-V controlled substances, and schedule III-narcotic controlled substances that are FDA-approved for opioid use disorder management and treatment.

Telemedicine 52

Telemedicine Provider Medical Patients 52

FDA Law

FEBRUARY 9, 2022

Improper Dosing for Pain Management. The Government alleged that Gulf Med regularly filled prescriptions for patients who traveled “an unusual distance” to obtain their prescriptions. The Government alleged that Gulf Med charged certain patients two to three times the market rate for their controlled medications. at 72,730.

IT 40

IT Insurance Government Patients 40

FDA Law

OCTOBER 17, 2023

In October 2022, FDA released the draft guidance entitled “Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Healthcare,” as previously discussed in our blog.

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

NOVEMBER 16, 2021

First, section 90006 imposes a moratorium on HHS’s implementation of an HHS OIG final rule, published on November 30, 2020, which amends the Federal health care program antikickback statute safe harbors as they apply to drug rebates paid to Medicare Part D plans and Medicaid Managed Care plans (or their PBMs).

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Manufacturing Utilities Management Provider 40