FDA Law Blog

FEBRUARY 13, 2025

Modifications to previously authorized PCCPs can be submitted via a Special 510(k), and eSTAR recommends that the manufacturer submit a clean copy and redline of the PCCP as an attachment. Manufacturers should develop the Modification Protocol consistent with their quality system and should follow their risk management processes.

Manufacturing 71

Manufacturing Management Specialization Provider 71

FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The final rule emphasizes risk management activities and risk-based decision making. Notably, Part 820 will look different.

Manufacturing 59

Manufacturing Management Medical IT 59

FDA Law Blog

SEPTEMBER 20, 2021

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. 31, 2022; CDRP start, FY 2023; Public workshop, by July 31, 2025; Strategy document published, by April 30, 2026.

Patient-Centered 52

Patient-Centered Manufacturing Clinic Provider 52

Alabama Academy of Family Physicians

FEBRUARY 19, 2025

It then establishes a new Rural Physician Income Tax Credit program, effective January 1, 2026, that provides a $10,000 annual tax credit to qualifying rural physicians for up to four tax years. Under this program, qualifying hospitals would receive gifts to support their provision of acute care services to rural populations.

Insurance 130

Insurance Management Hospital Vaccination 130

FDA Law Blog

AUGUST 3, 2021

Department of Health and Human Services in December 2020 to prevent Medicare Part D and Medicaid Managed Care plans from receiving rebates from manufacturers unless the rebates are passed through to pharmacies to reduce patient out-of-pocket expenses. See 42 C.F.R. 1001.952(h). See bipartisan bill summary at 5.

Manufacturing 52

Manufacturing Transportation Government Management 52

FDA Law Blog

SEPTEMBER 14, 2021

The most far reaching drug pricing provision of Subtitle E is an amendment to the Social Security Act to establish a Fair Price Negotiation Program applicable to Medicare Parts B and D as well as group and individual health plans in the commercial market. the amount Part D plans pay pharmacies for the drugs).

Manufacturing 52

Manufacturing Insurance Government Patients 52

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

Manufacturing 98

Manufacturing Supply Chain Patient-Centered Utilities 98