2027 Compliance FDA Licensing 
Innovaare Compliance
JANUARY 15, 2024
6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. Rebates from the selected drugs may change. Additional drugs will be selected for negotiation every year after 2025. [6]
SQA
FEBRUARY 15, 2023
Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Healthcare IT Today
JANUARY 19, 2024
are expected to reach $6 trillion by 2027, cost containment and the push to increased decentralization of care will be a top healthcare priority in 2024. Legacy point solutions will be a thing of the past as we move to platforms that deliver more scalable solutions that allow healthcare providers to perform at the top of their licenses.
SQA
MAY 24, 2023
The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers. The written procedure for recall was inadequate and this procedure had not been implemented.
Healthcare Law Blog
AUGUST 25, 2022
Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. Drugs eligible for negotiation must be FDA-approved for at least 7 years and marketed in conformance with the Federal Food, Drug, and Cosmetic Act. Program Compliance. Negotiation-Eligible Drugs.
Expert insights. Personalized for you.
52 
Let's personalize your content