IT, Manufacturing and Webinar - Primary Care Digest

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.

Manufacturing

Manufacturing Electronics Provider Management

HPM Director Dara Katcher Levy to Present Webinar on AMCP Format for Formulary Submissions v5.0

FDA Law Blog

JUNE 24, 2024

HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. To register for this insightful webinar, visit AMCP Learn. This afternoon Hyman, Phelps & McNamara, P.C.

Manufacturing

Manufacturing Healthcare Education Utilities

Integration of CEREC inLab and 3D Printing: Maximizing Same-Day Opportunities

CDOCS

JANUARY 12, 2021

They’re hosting a webinar on Thursday, January 14th to discuss this integration and how it can work in your dental practice.</p> By leveraging existing technologies such as CEREC inLab, 3D printing enables better responsiveness to patient needs, significantly reduces manufacturing times, and opens up new treatment options.

Manufacturing

Manufacturing Utilities Patients IT

CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement Discretion

FDA Law Blog

MARCH 7, 2022

At a high level, FDA will be allowing manufacturers a period of no less than 180 days to submit a premarket submission for devices marketed under an EUA or an enforcement policy. Manufacturers planning to continue commercial distribution to submit a premarket submission (e.g., Copies of the guidances can be found here and here.

Manufacturing

Manufacturing IT Relationship Medical

A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It

IT

IT Medical Patient-Centered Provider

FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

FDA Law Blog

JANUARY 2, 2025

FDA also plans to host a stakeholder webinar on the final rule at a later date. Therefore, manufacturers must maintain records for foods bearing a healthy claim unless it is clear from the foods mandatory labeling information. The final rule is effective 60 days from December 27, 2024, i.e., February 25, 2025.

Individual

Individual Manufacturing Provider IT

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. Finally, mark your calendars for the upcoming March 22, 2022 FDA webinar about this Guidance. The FDA webinar information can be found here.

Patients

Patients Clinic Medical Patient-Centered

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

FDA Law Blog

OCTOBER 10, 2023

We find that this information is noteworthy for manufacturers to consider. FDA encourages manufacturers to submit a pre-submission to discuss the animal study protocol with the Agency before submitting a 510(k) application.

Manufacturing

Manufacturing Engineering Clinic Patients

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

SEPTEMBER 20, 2021

When travel restrictions and public health precautions halt facilities inspections, many sponsors are left wondering how FDA will complete pre-approval inspections and meet their products’ respective PDUFA dates. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

Patient-Centered

Patient-Centered Manufacturing Clinic Provider

Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act

FDA Law Blog

MAY 19, 2022

If FDA concludes otherwise, proceeding to market with the formula could leave the manufacturer vulnerable to regulatory action. The guidance offers an opportunity that could be of special interest to foreign manufacturers who already market infant formula in other countries and have considered entering the U.S.

Manufacturing

Manufacturing Specialization Physicals IT

This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

FDA Law Blog

NOVEMBER 22, 2022

In an effort to correct some of the bottlenecks in traceability efforts, the final rule imposes additional recordkeeping requirements on domestic and foreign firms who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) for U.S. 7, 2022 at 1 p.m. EST. Attendees can register here or watch the livestream here.

Supply Chain

Supply Chain Illness Family Families

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

FDA Law Blog

FEBRUARY 20, 2025

That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. By Allyson B. Mullen & Jeffrey N. It did not.

Patient-Centered

Patient-Centered Consulting Government Clinic

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

FDA Law Blog

MAY 26, 2025

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. By Andrew J. Late last month the Attorney General issued a memo addressing both directives. First, it direct[s] all U.S. Genentech, Inc.,

Manufacturing

Manufacturing Provider Medical IT

Primary Care Digest

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

HPM Director Dara Katcher Levy to Present Webinar on AMCP Format for Formulary Submissions v5.0

Trending Sources

Integration of CEREC inLab and 3D Printing: Maximizing Same-Day Opportunities

CDRH Looks Towards the End of the Public Health Emergency and Transition for EUA and Devices Marketed Under Enforcement Discretion

A Final LDT Rule in April!? Will FDA be prepared?

FDA’s Final Rule on the Implied Nutrient Content Claim “Healthy” Maintains Focus on Foods Rather than on Nutrients

Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

Through Enforcement Discretion, FDA Facilitates Market Entry for New Infant Formulas (For Now); President Invokes Defense Production Act

This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

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

Navigating Executive Orders and DOJ Memos That Threaten Criminal Prosecution

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