HIT Consultant

MARCH 13, 2023

Seagen Background Seagen is a pioneer in ADC technology, with four of the twelve total FDA-approved and marketed ADCs using its technology industry-wide. billion of revenue in 20231, representing 12% year-over-year growth, from its four in-line medicines, royalties and collaboration and license agreements.

FDA 52

FDA Licensing 52

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]

Medicare 52

Medicare Medicare Compliance FDA 52

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.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

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.

Hospitals 114

Hospitals Governance FDA Licensing 114

SQA

MAY 24, 2023

The company did not have a written procedure in place for the provision of information related to serious risk of injury to health, contrary to what was committed to on it establishment license application. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

Hall Render

OCTOBER 27, 2023

Ransomware attacks against hospitals put patients’ lives at risk, researchers say States, FTC continue to target noncompetes: 3 updates The best hospital in each state, per Newsweek What to know about Stark law’s $9.2M with historic building purchase MICHIGAN Bronson raises capital campaign goal to $4.5M

US Department of Health and Human Services 40

US Department of Health and Human Services Nurses Nursing Homes Hospitals 40

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. Negotiation-Eligible Drugs.

Medicare 52

Medicare Medicare Medicaid Medicaid 52