FDA Law Blog

SEPTEMBER 20, 2021

When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and planned initiatives for the coming years, we were both excited by many of the announcements, while recognizing the real success will come from how the Agency implements them.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. Change to the IVD definition First, the mechanics of the change.

Provider 64

Provider Manufacturing IT Medical 64

FDA Law Blog

JUNE 14, 2023

Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level. Also, it is unclear which office within CDRH appoints the TAP Advisor, e.g., center-level, OPEQ-level, or division-level. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

Manufacturing 45

Manufacturing Medical Patient-Centered Appointment 45