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.

IT 69

IT Medical Patient-Centered Provider 69

FDA Law Blog

OCTOBER 10, 2023

Testing should be in line with the device’s intended duration of implantation, but FDA may consider whether testing results for a shorter duration can be extrapolated to provide information about long-term performance. We find that this information is noteworthy for manufacturers to consider.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

FDA Law Blog

SEPTEMBER 20, 2021

Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

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 52

Manufacturing Specialization Physicals IT 52

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 52

Supply Chain Illness Families Family 52

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.,

Patient-Centered 102

Patient-Centered Consulting Government Clinic 102

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. Specifically, these are procedures and drugs used in providing what HHS had, until recently, referred to as gender-affirming care.

Manufacturing 59

Manufacturing Provider Medical IT 59