DSCSA Saleable Return Requirements: What the Changes Mean

By |2020-11-20T09:34:26-05:0011/19/2020|

On October 22, the FDA issued a new guidance document: Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product – Compliance Policies The guidance includes a 3-year delay in enforcing the DSCSA's saleable returns verification requirement for distributors. The enforcement start date is [...]

Building the Downstream Commercial Supply Chain for Launch

By |2020-11-10T15:30:01-05:0008/28/2020|

An emerging pharmaceutical company was preparing for its first commercial product launches with two products progressing through the clinic. Approvals and launch events were targeted within one year of each other. The products were similar in technology and formulation. The first anticipated approval was for a relatively smaller indication. The second was for a [...]

New Challenges in Serialization and DSCSA

By |2020-11-09T15:05:53-05:0004/28/2020|

Converge Supply Chain Series webinar on 6/18/20 New Challenges in Serialization & DSCSA Now that federal DSCSA serialization regulations are being enforced for U.S. manufacturers, focus is shifting from first-time implementation to the challenges in serialization execution, management and delivery of business value. Forward-thinking companies are developing strategies for analyzing serialized data to identify [...]

Info Sheet: Serialization Execution

By |2020-11-09T11:35:18-05:0004/01/2020|

PDF Available > After delays in the U.S., federal DSCSA serialization regulations are in effect for manufacturers. EUFMD directives in Europe and other standards around the globe are advancing. The focus of Life Sciences manufacturers is shifting from serialization planning and preparation to serialization execution and management. Serialization is now a standard part of [...]

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