2026 IT Manufacturing Provider 
FDA Law Blog
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.
FDA Law Blog
JANUARY 18, 2023
The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance. The memorandum also introduced the Program’s spanking new logo.
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FDA Law Blog
OCTOBER 4, 2023
The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter. As such, that statute was unjust, confiscatory and violated their constitutional due process rights.
FDA Law Blog
SEPTEMBER 22, 2024
Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.
FDA Law Blog
NOVEMBER 16, 2021
5376 that has garnered the greatest amount of attention (at least in the food and drug law world) is TITLE XIII, Subtitle J (Drug Pricing), Part 1 (Lowering Prices Through Fair Drug Price Negotiation), Section 139001 (Providing for Lower Prices for Certain High-Priced Single Source Drugs). One of the new programs included in the H.R.
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.
FDA Law Blog
SEPTEMBER 20, 2021
Below we provide an overview of some of the goals letter’s most notable contents such as new initiatives as well as some large-scale enhancements to programs that have already been in the works. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).
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