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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. §

Management 52

Management Manufacturing Specialization IT 52

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The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ).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 provides definitions for the three datasets.

Manufacturing 71

Manufacturing Management Specialization Provider 71

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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. §

Management 40

Management Manufacturing Specialization IT 40

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.

Private Practice 52

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 11, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements.

Manufacturing 59

Manufacturing Management Provider Government 59

FDA Law

DECEMBER 9, 2024

The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements.

Manufacturing 59

Manufacturing Management Provider Government 59

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. Many federal agencies do have policies that provide a safe harbor for voluntary disclosures, but FDA does not.

Government 52

Government Provider IT Management 52

FDA Law

APRIL 6, 2025

For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. 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

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. §

Government 40

Government IT Provider Healthcare 40

FDA Law

MARCH 3, 2024

On March 1, the Office of Management and Budget (OMB) received the draft final LDT rule for review ( here ). It remains to be seen whether FDA’s hasty finalization of the rule will provide fodder for APA challenges for failing to adequately address substantive comments. That hasn’t happened yet.

Government 64

Government IT Management Provider 64

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

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. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

Board-Certified 52

Board-Certified Provider Government Management 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. Criterion 3 : Non-Device CDS software functions are intended for the purpose of supporting or providing recommendations about a patient’s care to a health care professional (HCP) user.

Clinic 52

Clinic Medical Provider Patients 52

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

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

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40

FDA Law

APRIL 23, 2021

The Supreme Court has handed down a decision in AMG Capital Management, LLC, et al. The Court also looked at the structure of the FTC Act beyond §13(b) to §5(l) and §19 which provide for the imposition of limited monetary penalties and awards of monetary relief where the FTC has already engaged in administrative proceedings.

Government 40

Government IT Transportation Provider 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. The Guidance provides practical guidelines for both firms and direct accounts. Product coding (e.g.,

Electronics 40

Electronics Manufacturing Provider IT 40

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

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

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

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. Other Updates With respect to the first part of the first criterion (i.e.,

Medical 53

Medical Diagnosis Healthcare Clinic 53

FDA Law

APRIL 8, 2024

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.” What about government factors that cause drug shortages? Section I.C

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

GeriPal

JANUARY 11, 2024

You get me with one-finger-chords on the guitar if you’re watching on YouTube (best I could manage). But there was this expectation once the Supreme Court ruling went through and as legislation was being developed that palliative care physicians would be the ones providing this. AMA PRA Category 1 credit(s) ™. Eric: Yeah.

Illness 144

Illness IT Medical Provider 144

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).

Manufacturing 40

Manufacturing Utilities Management Provider 40

FDA Law

FEBRUARY 11, 2024

The three letters together provide the range of actions DEA may take: no rescheduling from schedule I (former drug officials), rescheduling to schedule III (Democratic state attorneys general), or descheduling altogether (Democratic senators). (We We blogged on the December 5, 2023, letter from six Democratic governors to President Biden).

Medical 59

Medical Healthcare Professional Community IT 59

FDA Law

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. The rule was estimated to cost the federal government around $196 billion over ten years.

Manufacturing 52

Manufacturing Transportation Government Management 52

FDA Law

SEPTEMBER 14, 2021

This bill, which addresses numerous areas of the economy, public health, and government regulation, includes Subtitle E, Drug Pricing. A manufacturer that failed to provide access to the MFP would be subject to a civil monetary penalty of ten times the excessive price charged. Subtitle E is a slightly modified version of H.R.

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98