Implementing DSCSA: Stabilization Period and Expectations

U.S. Food and Drug Administration
U.S. Food and Drug Administration
3.1 هزار بار بازدید - 9 ماه پیش - In this on-demand webinar, FDA
In this on-demand webinar, FDA reviewed the Drug Supply Chain Security Act (DSCSA) implementation and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level. FDA also reviewed recent guidances for industry related to supply chain security requirements and other updates. FDA will clarify the stabilization period from November 27, 2023 - November 27, 2024.


Timestamps

01:15 – The Drug Supply Chain Security Act (DSCSA)

03:43 – Enhanced Drug Distribution Security Effective 11/27/2023

08:41 – Enhanced Drug Distribution Security: 2023 – 2024 Stabilization Period

12:08 – DSCSA-related Guidances for Industry

Speakers:

Leigh Verbois, PhD
Director | Office of Drug Security, Integrity, and Response (ODSIR)
Office of Compliance (OC) | CDER | FDA

Learn more at: https://www.fda.gov/drugs/news-events...

DSCSA Main Page:

• https://www.fda.gov/drugs/drug-supply...

DSCSA regulatory documents (I.e., regulations, guidances, federal register notices, pilot programs):

• https://www.fda.gov/drugs/drug-supply...

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9 ماه پیش در تاریخ 1402/08/12 منتشر شده است.
3,152 بـار بازدید شده
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