FDA Law Blog

SEPTEMBER 20, 2021

STAR aims to facilitate earlier access to novel uses of existing therapies for patients with a serious condition with unmet medical needs. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026. Notable Dates and Timelines – New MAPP published, by Dec.

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Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

JULY 7, 2024

Laboratories struggling to understand the myriad implications of being regulated as device “manufacturers” were hopeful that additional guidance would shed light on how to apply FDA’s existing medical device regulatory framework to their operations. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

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FDA Law Blog

JUNE 14, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — “Total Product Life Cycle Advisory Program or TAP pilot — the most exciting thing in MDUFA V. According to Dr. Shuren, the TAP Advisor acts as a consultant, engaging with companies to identify key questions, challenges, and areas requiring strategic problem-solving.

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Manufacturing Medical Appointment Patient-Centered 45

FDA Law Blog

FEBRUARY 20, 2025

In contrast, AMP and ACLA both asserted that the rule would harm medical care. That, of course, is not unique to labs with LDTs; kit manufacturers also need to obtain those insights well before they begin studies.) In addition, we understand that at this time FDA is unable to consult outside experts.

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