Events, Government, Manufacturing and Provider

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

Medical

Medical Manufacturing Healthcare Government

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

FDA Law

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. 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. On March 20-21, Counsel John W.M.

Manufacturing

Manufacturing Management Specialization Government

FIFA Cases Hold Lessons for FDA-Regulated Companies – Organizations can be Victims of Their Own Employees’ Criminal Conduct

FDA Law

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. Generally speaking, that recognition has limits, however.

Government

Government Manufacturing Individual IT

Webinars

How to Start Virtual Care the Right Way: A Proven Roadmap for 2025 and Beyond

MORE WEBINARS

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Law

JANUARY 18, 2022

In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” The discussion paper provides an overview of FDA’s current approach to regulation of 3D-printed devices. use in education, construction, art, and jewelry).

Medical

Medical Manufacturing Healthcare Government

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

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. Therefore, the events surrounding this particular Warning Letter preceded the LDT decision. By Steven J.

IT

IT Manufacturing Government Clinic

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

FDA Law

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well. By John W.M.

Manufacturing

Manufacturing Patient-Centered Provider Telehealth

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. If held in a third-party venue, the venue “should not be extravagant or the main attraction of the event” (e.g.,

Specialization

Specialization Manufacturing Education Provider

In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law

FEBRUARY 26, 2025

With all the change we are witnessing in the American model of regulation and governance, it might be tempting to ask if we are suddenly living in a post-compliance word. The answer to that is still no, the current state of world and governmental events notwithstanding. HPM Counsel John W.M.

Supply Chain

Supply Chain Management Manufacturing IT

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

FDA Law

JUNE 12, 2023

As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee. They have inspectors in the field everyday with eyes on the products, on the local manufactures, and on the distributors and retailers.

Manufacturing

Manufacturing Individual Government Illness

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

GeriPal

DECEMBER 7, 2023

And so any additional stressor such as heat or an extreme weather event or having to move from your home because of a climate related disaster can really tax an older adult whose window of resilience is more limited. What do we do to very concretely provide heat shelters and cool shelters?

Healthcare

Healthcare IT Education Community

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

FDA Law

JANUARY 24, 2024

Section 1 of the Executive Order laid out the Biden Administration’s policy to, among other things, “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”

Supply Chain

Supply Chain Manufacturing Government Provider

New Administration, “Old” Rules: FDA and HHS Jointly Withdraw 11th Hour Trump Administration Proposal for Sweeping 510(k) Exemption

FDA Law

APRIL 21, 2021

In support of this proposal, the Notice looked only to FDA’s publicly available device adverse event database, FDA’s Manufacturer and User Facility Device Experience (MAUDE), to identify any safety risks. 393(d)) provides that the Secretary ‘shall be responsible for executing’ the FD&C Act ‘through the [FDA] Commissioner.’

Manufacturing

Manufacturing Government IT Consulting

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Law

FEBRUARY 20, 2025

Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) It did not.

Patient-Centered

Patient-Centered Consulting Government Clinic

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law

JANUARY 9, 2024

This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. The government would require at least another 30 days to examine the shipment at the U.S.

Supply Chain

Supply Chain Manufacturing Chronic Condition Government

Primary Care Digest

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

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

Webinars

Trending Sources

FIFA Cases Hold Lessons for FDA-Regulated Companies – Organizations can be Victims of Their Own Employees’ Criminal Conduct

Webinars

FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of Care

FDA Abandons Its Defense of the LDT Rule, But is It Signaling an Increase in RUO Scrutiny?

As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health Enforcement

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

In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

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

A Bold Goal: Reshoring 25% of Small Molecule API to the U.S. in 5 Years – APIIC’s Report to The White House

New Administration, “Old” Rules: FDA and HHS Jointly Withdraw 11th Hour Trump Administration Proposal for Sweeping 510(k) Exemption

Decades of LDT Tension Leads to an Epic Three-Hour Oral Argument

FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

Stay Connected