Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. Stage 3: Effective May 6, 2027 Three years after the Final Rule’s publication, the FDA will enforce all remaining quality system requirements (under 21 C.F.R.

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

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

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

SQA

OCTOBER 18, 2024

Most synthetic injectable peptides are regulated as prescription drugs in Canada and require a prescription from a licensed healthcare professional. The deadline to submit feedback for this plan is 25 July 2024. is recalling one lot of ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion in 60 mL bottles.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

Most synthetic injectable peptides are regulated as prescription drugs in Canada and require a prescription from a licensed healthcare professional. The deadline to submit feedback for this plan is 25 July 2024. is recalling one lot of ratio-ECTOSONE (TEVA-ECTOSONE) 0.05% mild lotion in 60 mL bottles.

FDA 40

FDA Compliance Public Health Governance 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.

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Medicare Medicare Medicaid Medicaid 52