Agency IQ

SEPTEMBER 29, 2023

Due to the presence of nitrosamines in certain drug products, FDA had required that drug manufacturers conduct an initial risk assessment of approved or marketed products, with an initial completion date of October 1, 2021, and then confirmatory testing due by October 1, 2023.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

December 2023 Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule) The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). to include devices.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

December 2023 Banned Devices; Electrical Stimulation Devices Intended for Self-Injurious Behavior or Aggressive Behavior (Proposed Rule) The Food and Drug Administration (FDA) is proposing to ban electrical stimulation devices (ESDs) intended for self-injurious behavior (SIB) or aggressive behavior (AB). to include devices.

FDA 40

FDA Science Regulations Production 40