FDA Law Blog

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law Blog

DECEMBER 3, 2023

On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.

Manufacturing 105

Manufacturing Provider IT Electronics 105

FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2]

Manufacturing 64

Manufacturing Provider Physicals Electronics 64

FDA Law Blog

NOVEMBER 22, 2022

When necessary to help prevent or mitigate a foodborne illness outbreak or assist in implementing a recall, firms must generally provide an electronic sortable spreadsheet containing information that FDA requests on specified CTEs, FTL foods, date ranges, and TLCs. 7, 2022 at 1 p.m.

Supply Chain 52

Supply Chain Illness Family Families 52

Physician's Weekly

JUNE 26, 2025

The HHS budget proposal for fiscal year 2026 makes no mention of vaccine safety programs. CDC vaccine safety officer Robert Chen built on VAERS to create the Vaccine Safety Datalink, which looks for evidence of vaccine harms in electronic health records. Kennedy Jr. forced him out in May. The current U.S.

Vaccination 52

Vaccination Patient-Centered Government IT 52