Government, Manufacturing, Provider and Specialization

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

FDA Law Blog

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

MN Legislative Session 2025: Updates on Health Care Bills

Minnesota Academy of Family Physicians

MARCH 27, 2025

As we move into the tenth week of the legislative session, Minnesota Academy of Family Physicians (MAFP) lobbyist Megan Verdeja breaks down what’s happening at the Minnesota State Capitol and provides an update on health care bills. The bill passed by a voice vote and was referred to the State and Local Government Committee.

Family Physician

Family Physician Insurance Finance Individual

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

FDA Law Blog

FEBRUARY 13, 2025

In fact, eSTAR does not allow a PCCP to be included in a Special 510(k); attempting to do so results in the message if you are establishing a PCCP this should not be done in a Special 510(k). Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

Manufacturing

Manufacturing Management Specialization Provider

Companies Shipping Chemicals: “Know the One You’re Dancing With”

FDA Law Blog

MAY 4, 2025

Both chemicals are used in the illicit manufacturer of fentanyl. 1-BOC-Piperidone is a DEA-regulated List 1 chemical while (2-Bromethyl) benzene is on DEAs longstanding, recently updated Special Surveillance List. The government determined that the chemicals had been imported into the U.S.

Manufacturing

Manufacturing Government Specialization IT

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

FDA Law Blog

MARCH 6, 2024

Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. We can offer our readers a special discount for the event. The discount code is S10-896-896L24.S.

Management

Management Manufacturing Specialization Government

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

FDA Law Blog

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

Referral

Referral Relationship Government Healthcare

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

FDA Law Blog

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

Manufacturing Specialization Government IT

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. Background.

Management

Management Manufacturing Specialization IT

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

FDA Law Blog

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. 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.

Consulting

Consulting Provider Manufacturing Specialization

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

FDA Law Blog

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. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. Background.

Management

Management Manufacturing Specialization IT

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

FDA Law Blog

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. In this case, the Supreme Court provided greater clarity on how to interpret that requirement. What was SuperValu all about?

Government

Government Patient-Centered IT Manufacturing

Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog

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

Government Manufacturing IT Utilities

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

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

Supply Chain Manufacturing Government Hospital

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

GeriPal

DECEMBER 7, 2023

I actually wonder though, since we’re on a GeriPal broadcast, I think that people are under emphasizing the special risk of older people. So if you look at government websites about heat for example, it’s got a line of buttons across the top with affected populations, outdoor workers, athletes and older people are in there.

Healthcare

Healthcare IT Education Community

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

FDA Law Blog

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. Radical Transparency. Deregulation Efforts.

Manufacturing

Manufacturing Specialization IT Provider

Primary Care Digest

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

MN Legislative Session 2025: Updates on Health Care Bills

Trending Sources

Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

Companies Shipping Chemicals: “Know the One You’re Dancing With”

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

Get the 4-1-1 on your 1099s: 5th and 7th Circuits Permit Paying Volume-Based Compensation to Independent Sales Agents

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

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

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

I Hear You Knockin’… Preparing for and Managing DEA Inspections (Part 1)

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

Skinny Label and Induced Infringement: The Saga Continues

Does the Drug Shortage White Paper Fall Short?

Aging and Climate Change: Karl Pillemer, Leslie Wharton, & Ruth McDermott-Levy

“Radical Transparency” and “Deregulation” from Trump and RFK Jr.’s FDA. Unless it’s Useful to the Device Industry

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