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DSCSA Information

WEBDefinitions & 2015 Obligations. The DSCSA establishes a new system for traceability of prescription drug products through phased-in requirements for manufacturers, …

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URL: https://pdsaonline.org/dscsa-information/

Energy & Commerce Subcommittee on Health Hearing: Securing …

WEBEnergy & Commerce Subcommittee on Health Hearing: Securing Our Nation’s Prescription Drug Supply Chain Source: U.S. House of Representatives Energy and Commerce …

Category:  Health Go Health

The Healthcare Distribution Management Association

WEBThe Healthcare Distribution Management Association. HDMA is the national association representing primary pharmaceutical distributors, the vital link between the nation’s …

Category:  Health Go Health

Resources Archive

WEBEnergy & Commerce Subcommittee on Health Hearing: Securing Our Nation’s Prescription Drug Supply Chain Source: U.S. House of Representatives Energy and Commerce …

Category:  Health Go Health

Hearings Archives

WEBEnergy & Commerce Subcommittee on Health Hearing: Securing Our Nation’s Prescription Drug Supply Chain Source: U.S. House of Representatives Energy and Commerce …

Category:  Health Go Health

White Paper 1: A Proposal: Governance for DSCSA Phase II …

WEBTo do so, the governance body is expected to: 1. Define use cases and guidelines for communication between trading partner networks to facilitate interoperability, as …

Category:  Health Go Health

PDSA Position Statement on Administration’s Importation Final Rule

WEBSource: PDSA Position Statement on Administration's Importation Final Rule. The Pharmaceutical Distribution Security Alliance (PDSA) released the following statement …

Category:  Health Go Health

Preemptive Effect of DSCSA

WEBThe content and statements in this document are provided for informational purposes only by the Pharmaceutical Distribution Security Alliance, a coalition

Category:  Health Go Health

An Overview: PDSA Vision for Phase II Interoperability and …

WEBWe believe the vision for Phase II described in this series of white papers is a significant step forward on the path to implementation and will advance the collective dialogue …

Category:  Health Go Health

DSCSA Implementation: Product Tracing Requirements

WEBContains Nonbinding Recommendations 1 DSCSA Implementation: Product Tracing Requirements — Compliance Policy . Guidance for Industry. 1. This guidance …

Category:  Health Go Health

Complying with the Authorized Trading Partner Requirements …

WEBEric Marshall is a member of the Faegre Baker Daniels Health Care and FDA practice where he advises health and life science clients on a variety of regulatory and …

Category:  Health Go Health

Guidance for Industry: DSCSA Implementation: Annual …

WEB1. 2 . Drug Supply Chain Security Act Implementation: 3 . Annual Reporting by Prescription Drug Wholesale Distributors and 4 . Third-Party Logistics Providers

Category:  Health Go Health

April 27, 2020 Dr. Leigh Verbois, Ph.D. Director, Office of Drug

WEB3 “(1) In general.--Not later than 2 years after the date of enactment of the Drug Supply Chain Security Act, the Secretary shall issue regulations regarding the standards for …

Category:  Health Go Health

May 14, 2015 Dr. Ilisa Bernstein Food and Drug …

WEBMay 14, 2015 Dr. Ilisa Bernstein Deputy Director, Office of Compliance Food and Drug Administration 10903 New Hampshire Avenue Bldg. 51, Rm 5271

Category:  Food Go Health

FDLI’S DRUG and

WEBfdli the food and drug law institute 1155 15th street nw. suite 800 // washington, dc 20005 www.fdli.org food // drugs // animal drugs // biologics // cosmetics // diagnostics // dietary …

Category:  Food Go Health

DSCSA Implementation: Product Tracing Requirements for …

WEBPhone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353

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September 24,2013

WEBSeptember 24,2013 The Honorable Tom Harkin The Honorable Fred Upton Chairman Chairman Committee on Health, Education, Labor and Pensions Committee on Energy …

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Guidance for Industry: DSCSA Implementation: Annual …

WEBContains Nonbinding Recommendations Draft — Not for Implementation 2 42 II. BACKGROUND 43 . 44 On November 27, 2013, the DSCSA (Title II of Public Law 113 …

Category:  Health Go Health

Resources Archive

WEBPDSA Letter Re: Implementation of the January 1, 2015 DSCSA Requirements Source: PDSA Given the interconnected nature of the supply chain, we are encountering a large …

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