2026 Government Manufacturing Medical 
FDA Law
FEBRUARY 13, 2025
Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). FDA recommends including only a limited number of modifications in the PCCP.
FDA Law
AUGUST 14, 2022
The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year.
FDA Law
FEBRUARY 20, 2025
Given the numerous changes in policy by the Trump administration, there had been much speculation that the government would now take a different position on this Biden-era rule. In contrast, AMP and ACLA both asserted that the rule would harm medical care. Perhaps most notable in yesterdays argument, though, was what didnt happen.
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