Manufacturing, Presentation and Specialization

PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

FDA Law

AUGUST 23, 2021

Kirschenbaum — On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals , which takes effect on January 1, 2022. Department of Health and Human Services (OIG) (see our blog post on this Special Fraud Alert here ).

Specialization

Specialization Manufacturing Education Provider

Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

FDA Law

OCTOBER 3, 2022

HHS noticed an increasing trend of illegal kickbacks in connection with speaker programs and in November 2020, the Office of Inspector General issued a Special Fraud Alert on the topic. The Alert described several factors that could potentially violate the antikickback statute.

Consulting

Consulting Healthcare Professional Specialization Government

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

FDA Law

MAY 19, 2023

In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results, and incorrect operation of the device. The Special Controls are silent on what would constitute appropriate levels of evidence necessary to satisfy this criterion. analytical, clinical and stability).

Specialization

Specialization Clinic Provider IT

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

MAY 8, 2023

Manufacturers should be able to verify and validate the proposed modifications within their existing quality system. Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission.

Manufacturing

Manufacturing Provider Medical IT

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA Law

JUNE 28, 2021

On June 26, 2021, during the Minnesota legislature’s special session, the Minnesota House of Representatives passed HF33, an omnibus health and human services bill. The companion bill was already passed by the Minnesota Senate and has a presentment date of today, June 28, 2021.

Hospital

Hospital Manufacturing Specialization Medical

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

FDA Law

OCTOBER 31, 2022

It seems that FDA may have validated that, even with an Excellence Appraisal above and beyond standard compliance with good manufacturing practices, there is a need for pre-market review for Class 2 devices. Despite the limitations in testing, some of the findings were noteworthy.

Manufacturing

Manufacturing Specialization Management IT

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

FDA Law

MARCH 6, 2024

His presentation will focus on “MoCRA is Here – Now What? Featuring speakers from the USPTO, FTC, FDA, distinguished members of the Judiciary, and in-house and outside counsel, HP&M Director Kurt Karst will be a presenter at the 20th Annual Paragraph IV Disputes Conference , April 25 – 26 in New York, NY.

Management

Management Manufacturing Specialization Government

The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.

Manufacturing

Manufacturing Engineering Medical IT

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Law

NOVEMBER 20, 2024

Chemical characterization can also be useful in evaluating a change to the materials or manufacturing of a device. FDA suggests that test articles represent the worst-case manufacturing process, and provide the examples that the device undergoes the greatest number of sterilization and/or reprocessing cycles.

Provider

Provider Medical Manufacturing Consulting

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

FDA Law

OCTOBER 25, 2021

Specifically, for 510(k)s, QSR inspections are prohibited unless FDA finds that “there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health.” FDCA § 513(f)(5). 515(d)(2)(C). 54,826, 54,832 (Oct.

Manufacturing

Manufacturing Specialization Government IT

Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

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

Consulting Provider Manufacturing Specialization

Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement

FDA Law

JUNE 7, 2023

Doing business with the federal government comes with numerous restrictions and special provisions in exchange for the benefit of having access to Federal reimbursements.

Government

Government Patient-Centered IT Manufacturing

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. If the registrant has a manufacturing or import quota, the investigators may ensure the registrant has not exceeded their established quota.

Management

Management Consulting Provider Physicals

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

FDA Law

MAY 20, 2021

At least two investigators must be present during the on-site inspection, but teams can include DEA special agents or task officers from state and local law enforcement and regulatory agencies. If the registrant has a manufacturing or import quota, the investigators may ensure the registrant has not exceeded their established quota.

Management

Management Consulting Provider Physicals

Skinny Label and Induced Infringement: The Saga Continues

FDA Law

MAY 11, 2023

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.” It’s important to note here that the Government’s brief was signed by both FDA and the USPTO.

Government

Government Manufacturing IT Utilities

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

GeriPal

MAY 8, 2025

Alex 00:59 And I met all three of you and watched you do a presentation about psilocybin research at the Congress International Desens Palliative Miguel. So in our trial, because of security reasons, we are required by Health Canada to store the substance in a special secure area in my office. Ali John, welcome to the GeriPal Podcast.

Illness

Illness IT Patient-Centered Patients

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

FDA Law

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. Unapproved prescription drugs present serious safety and effectiveness concerns. Please bear with us.) it is illegal to import.

Manufacturing

Manufacturing IT Individual Provider

Primary Care Digest

PhRMA Code Revised in Response to OIG Special Fraud Alert on Speaker Programs

Biogen agrees to pay $900 million in largest FCA Settlement Ever Secured without Government’s Intervention

Trending Sources

Well Isn’t that Special: An Assessment of the Special Control Associated with Simple Point of Care COVID-19 Antigen Tests

Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

Minnesota Proposes to Reduce Opioid Product Registration Fees Related to Hospitals

FDA’s Pre-Cert Pilot Ends. Will there be a Sequel?

ACI To Host Multiple Events Featuring HP&M Speakers – Discounts Available to FDA Law Blog Readers

The New FDA Draft Human Factors Guidance: A Bridge Too Far

New Draft Guidance Provides Detailed (and Burdensome) Recommendations for Chemical Assessments to Support Medical Device Biocompatibility

FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule

Conference Notebook: Reporting from FDLI’s 2023 Enforcement, Compliance, and Litigation Conference

Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter Requirement

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 2)

Skinny Label and Induced Infringement: The Saga Continues

Psilocybin in Serious Illness: James Downar, Ali John Zarrabi and Margaret Ross

What Does the “Most Favored Nation” Executive Order Mean for Personal Use Imports?

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