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DSCSA Update – FDA Extends Deadline for Connected Trading Partners to Meet Requirements

Hall Render

Food and Drug Administration (“FDA”) issued two compliance policies that outlined its strategy for enforcing the drug distribution security requirements established by the Drug Supply Chain Security Act (“DSCSA”), which were set to take effect on November 27, 2023.

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From Discretion to Regulation: What FDA’s Final Rule Means for Laboratory Developed Tests

Hall Render

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.

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Understanding the 2025 Medicare Part D Re-design: What You Need to Know

Innovaare Compliance

CMS will implement negotiated pricing based on maximum fair price (MFP) in 2026 on ten (10) selected drugs. 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.

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Health Provider News

Hall Render

Acentra Health Awarded $27.5M Braun Signs Hospital Pricing Bill Into Law Lilly breaks ground on $4.5B and Virginia hospitals land on national honor roll with drop in errors, infections, injuries Three Va.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – January

SQA

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. Finalization of the document is planned for 2026. Health Canada Health Canada Inspection of Applied Chemistry Labs Ltd.,

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SQA Regulatory Surveillance Summary for 3Q/4Q 2024

SQA

This summary highlights significant shifts from agencies like ANVISA, the FDA, EMA, NMPA, and others, covering cosmetics surveillance, Artificial Intelligence in medical devices, and updated GMP practices. Specifically, the agents for overseas registrants would need to have either device distribution licenses or device manufacturing licenses.

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SQA Regulatory Surveillance Summary | Monthly Update 2023 – March And April

SQA

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.

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