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

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

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

Hall Render

MARCH 11, 2022

FDA final guidance presses industry to be ‘recall ready’ Final vaccine mandate deadlines still in play, despite removal vote. Nurses are waiting months for licenses as hospital staffing shortages spread. Nurses are waiting months for licenses as hospital staffing shortages spread. in capital projects by 2028.

COVID-19 40

COVID-19 US Department of Health and Human Services Nursing Homes Nurses 40