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.

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FDA Law Blog

DECEMBER 11, 2023

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap.

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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.

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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. separate patient labeling). separate patient labeling).

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FDA Law Blog

SEPTEMBER 20, 2021

The discussion and public comments during this workshop will inform a new strategy document with actions the Agency will take during PDUFA VII to advance the utilization of innovative manufacturing technology. Notable Dates and Timelines – New MAPP published, by Dec. 31, 2022; Publish notice of the CDRP program, by Dec.

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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.

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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.

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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. The last time CDRH was significantly resource constrained (i.e.,

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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. A pre-enforcement challenge is not the only option, of course. Defenses can also be raised during an investigation.

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