FDA Law

AUGUST 26, 2021

To hold a corporation liable for these actions, the government must establish that the corporate agent’s actions (i) were within the scope of his duties and (ii) were intended, at least in part, to benefit the corporation. In light of the above, the government generally resists the notion that an organization is a victim of its own employees.

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FDA Law

MAY 15, 2025

Gaulkins presentation, Product Price Increases: A SPTR Practical Walkthrough , will provide an interactive case study outlining the hypothetical enforcement, appeal, and settlement scenarios that may apply to qualifying drug price increases. FDA Law Blog readers are offered a discount of 10% off the registration price.

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FDA Law

JUNE 30, 2022

As the drug distribution industry is well aware, and as blogged about here , on February 4, 2022, FDA published its long-awaited proposed rule titled “ National Standards for the Licensure of Wholesale Drug Distributors and Third-party Logistic Providers ” (87 Fed. 2) State regulation of third-party logistics providers.

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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.

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Vaccination Individual Government Provider 98

FDA Law

FEBRUARY 27, 2025

Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. The guideline expands its focus on data governance and clearly defines the roles and responsibilities of sponsors, investigators, and service providers.

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FDA Law

JUNE 28, 2022

21-5261, 597 U.S. _ (2022), the Supreme Court ruled that the government must prove — beyond a reasonable doubt — that a prescriber knew or intended that a prescription was not lawful in order to subject that prescriber to criminal penalties under the federal Controlled Substances Act (CSA). United States, No. 21 U.S.C. § 841 (emphasis added).

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FDA Law

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

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FDA Law

FEBRUARY 6, 2024

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. Mr. Claud was joined in his testimony by Mary Denigan-Macauley , a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. FDA was invited to attend but did not.

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FDA Law

MARCH 4, 2024

Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. FDA Law Blog readers can use the discount code 24SPKR150 for reduced registration fees.

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FDA Law

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information.

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Patient-Centered Telehealth IT Government 105

FDA Law

JANUARY 30, 2025

As the DOJ FOIA Guide explains in its introduction : The United States Supreme Court has explained that [t]he basic purpose of [the] FOIA is to ensure an informed citizenry, vital to the functioning of a democratic society, needed to check against corruption and to hold the governors accountable to the governed. 552(a)(4)(B).

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Government Electronics Provider IT 66

FDA Law

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional. Order at 24.

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Provider Manufacturing IT Government 59

FDA Law

OCTOBER 8, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment. DEA next hosted Telemedicine Listening Sessions on September 12 and 13, 2023, for which it receive over 180 requests to present.

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Telemedicine Relationship IT Mental Health 64

FDA Law

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

Clinic 64

Clinic Clinical Practice Provider Utilities 64

FDA Law

OCTOBER 26, 2022

In the interim, the issue has reared its head again in FDA’s recently issued guidance for industry, titled Refusal of Inspection by a Foreign Food Establishment or Foreign Government. . That refusal is executed administratively, with no need to involve lawyers or judges, and the results can be highly disruptive. See here and here.

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Government Physicals IT Provider 59

FDA Law

JANUARY 18, 2022

In May 2016, FDA released a draft guidance document titled “Technical Considerations for Additive Manufactured Devices” (see our blog post on the draft guidance here ), which was finalized in 2018 (see our blog post on the final guidance here ). This guidance document is still in effect today. products intended for medical purposes).

Medical 75

Medical Manufacturing Healthcare Government 75

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. The discount code is: S10-826-826L24.S.

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Private Practice Government Specialization Management 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

ABIM

MAY 18, 2025

This burden of the disease is being felt by patients and healthcare providers. Worse yet, patients may avoid speaking up, even with their own providers, while suffering silently in pain. i] [link] The post A patient’s perspective: The evolving landscape of IBD first appeared on ABIM Blog.

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Diagnose Healthcare Diagnosis Physicals 40

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. Mallory , 988 F.3d 3d 730 (4th Cir. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th Polin , 194 F.3d

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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.

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FDA Law

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S.

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Government Provider Community Individual 59

FDA Law

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. By David B. Clissold & Sara W. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

Manufacturing 115

Manufacturing IT Provider ER 115

FDA Law

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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IT Manufacturing Government Clinic 64

FDA Law

JULY 8, 2024

The Seventh amendment provides that in “suits at common law, where the value in controversy shall exceed twenty dollars, the right of trial by jury shall be preserved, and no fact tried by a jury, shall be otherwise reexamined in any court of the United States.” So the SEC has the option of retrying Jarkesy in a district court.

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Government IT Provider Clinic 59

FDA Law

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. As such, we will publish a separate blog post focused on confirmatory trials and how FDA is interpreting this key provision of its accelerated approval authority.

Clinic 64

Clinic Relationship Provider IT 64

FDA Law

JUNE 23, 2022

The conference will feature speakers from government and industry who will provide updates on the latest developments in regulation, legislation, and litigation specific to this diverse and expanding product category. Hyman, Phelps & McNamara, P.C.’s

Government 52

Government Provider 52

FDA Law

AUGUST 15, 2021

FDA has now issued a final rule governing how intended use of a distributed product is to be determined. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. Thus ends a saga that began with a proposal in 2015 to amend the “intended use” regulation.

Manufacturing 93

Manufacturing IT Provider Government 93

FDA Law

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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FDA Law

JANUARY 31, 2022

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 ).

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Government IT Provider Healthcare 40

FDA Law

MARCH 1, 2023

Before discussing the 2023 paper, it’s important to know that the QMM Program is separate from the Quality Metrics Program , which we previously blogged about here , here , and here. In addition to providing some background on QMM, the FDA presented lessons learned from the QMM Program Pilots.

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FDA Law

NOVEMBER 10, 2022

Unlike virtually all DEA/DOJ civil settlements that we are aware of, the government recently announced a settlement not with a DEA registrant but with non-registered retail inventory service providers. Then something novel comes along. While no registrant is a party to the settlement, as the U.S. 29, 2022), at [link]. a), 1307.03.

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Government Provider IT 59

FDA Law

APRIL 22, 2025

By law, DEA must provide you with notice and an opportunity for a hearing before it can take away your registration (or deny your application), so DEA will issue an Order to Show Cause, which explains the legal grounds for revoking or denying a registration and informs you of your right to challenge DEAs decision.

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Government Provider Consulting Manufacturing 52

FDA Law

JANUARY 18, 2023

By Faraz Siddiqui — Last week, the Centers for Medicare & Medicaid Services (CMS) released a memorandum on how it intends to implement the Medicare Drug Price Negotiation Program, passed under the Inflation Reduction Act (IRA) (see our blog post and slide deck on IRA). The memorandum also introduced the Program’s spanking new logo.

Manufacturing 59

Manufacturing IT Provider Government 59

FDA Law

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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Medical Provider IT Manufacturing 59

FDA Law

OCTOBER 25, 2021

Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. Yet, all this time, this process lacked implementing regulations governing the process and the criteria for approval. Part 807, Subpart E). In 1986, FDA followed up with the PMA regulations (21 C.F.R. The regulatory uncertainty has ill?befitted

Manufacturing 52

Manufacturing Government Specialization IT 52

FDA Law

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R.

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Manufacturing Patient-Centered Healthcare Utilities 83