Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline

By |2024-06-25T16:52:33-04:0005/22/2024|

Webinar on June 20 @ 12-1p ET Navigating Serialization Compliance to Meet November’s FDA Enforcement Deadline Join us for a webinar with experts on navigating serialization compliance and beyond. Discussion will range from the most critical aspects of the new requirements to best practices for dealing with requests and exceptions. You will [...]

Converge Perspective on the FDA Delayed Enforcement

By |2023-09-07T11:02:48-04:0009/07/2023|

Converge Perspective on the FDA Delayed Enforcement Originally published on the MassBio News & Thought Leadership blog On June 2, 2023, the Healthcare Distribution Alliance (HDA) submitted to the Federal Drug Administration (FDA) a letter outlining challenges for implementing the last mile of DSCSA compliance. Chief among these is manufacturers’ inability to [...]

Commercial Launch Planning on an Accelerated Timeline

By |2024-02-06T10:20:01-05:0002/13/2023|

Commercial Launch Planning on an Accelerated Timeline PDF Version An emerging European biotech company was preparing to commercially launch its first product in the US. The FDA granted the innovative product a priority review given the potential for significant benefit to patients. As a result, the company faced a compressed timeline to [...]

Implementing a Serialization Program Successfully on the First Try

By |2024-02-06T10:06:36-05:0001/18/2022|

Implementing a Serialization Program Successfully on the First Try PDF Version An emerging specialty biopharmaceutical company was preparing for the U.S. launch of their first drug product. Building out their supply chain would involve implementing a serialization program to meet Drug Supply Chain Security Act (DSCSA) requirements. While Supply Chain team members [...]

2022 & Beyond: Serialization Requirements for Manufacturers

By |2023-01-03T15:22:15-05:0012/13/2021|

Life Sciences Supply Chain Working Group Webinar January 20, 2022 @ 12-1p ET 2022 & Beyond: Serialization Requirements for Manufacturers Read the Event Recap The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing [...]

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022

By |2021-12-07T12:19:34-05:0011/16/2021|

Pushing “Fast Forward” on Serialization Requirements: What Manufacturers Need to Do for 2022 Originally published as a MassBio Guest Blog Stephanie L Byrne is a senior supply chain consultant and serialization lead focusing on DSCSA project leadership. She has helped more than a dozen life sciences companies realize the greatest impact from [...]

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors

By |2021-11-16T08:50:29-05:0011/16/2021|

2022 Industry Serialization Requirements: Assessing 3PL Options for Sending EPCIS Data to Distributors Pharmaceutical manufacturers currently share transaction data with their trading partners at the lot level. The Drug Supply Chain Security Act (DSCSA) mandates package level traceability by November 2023. Cardinal Health and McKesson are requiring that manufacturers provide fully aggregated [...]

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements

By |2021-11-08T17:08:01-05:0011/08/2021|

Manufacturers Need to Start Now to Prepare for 2022 Serialization Requirements While the Drug Supply Chain Security Act (DSCSA) does not require manufacturers to send package-level serialization data downstream until November 27, 2023, the Big 3 distributors are accelerating this timeline and requiring that data by November 2022. Cardinal Health and McKesson [...]

5 Unique Logistics Challenges for Specialty Pharmaceuticals

By |2024-02-06T11:12:39-05:0007/28/2021|

5 Unique Logistics Challenges for Specialty Pharmaceuticals Many of our clients are innovator companies developing novel treatments that are often complex and extremely high value. As a result, they face similar supply chain challenges in preparing for commercialization. Often, these specialty products are also orphan and rare disease treatments, as well as extremely [...]

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