Featured Pharma Online Editorial

1. PDG-FDA Town Hall Notes — DSCSA Readiness Is At Hand 4/24/2025

   Data quality and exceptions handling were key discussion points during a March PDG-FDA town hall, where stakeholders shared updates on progress and unfinished work.

2. Digital Certificates Of Analysis: A Vision For The Transfer Of Quality Data 1/23/2025

   The pharma/biotech industry must ramp up adoption of digital certificates of analysis, which are transforming the way quality data is transferred between organizations in the supply chain.

3. Will FDA Finally Enforce DSCSA Interoperability In 2025? 12/26/2024

   Two experts weigh in on the persistent problems surrounding the Drug Supply Chain Security Act and its upcoming enforcement deadlines.

4. 3 Focus Areas To Transition From Clinical To Commercial Readiness 11/12/2024

   Transitioning from clinical-stage operations to commercial readiness is a multifaceted process. Establish compliant and robust distribution systems by focusing on these three areas.

5. What's Next After FDA's DSCSA Extension? 10/18/2024

   Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

6. Data Quality Issues At The Heart Of FDA's DSCSA Troubles 10/18/2024

   Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.

7. Should You Be Using Unique Container Identification? 8/22/2024

   Unique identifiers on glass vials could solve a host of problems. ISPE developed a new guide to help manufacturers apply them on primary parenteral containers.

8. Addressing Challenges In Serialization For Complex Therapeutics 5/7/2024

   The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.

9. Emerging Trends & Technologies In Anti-Counterfeit Pharmaceutical Packaging 11/21/2023

   Counterfeit medicines are rising at an alarming rate, with data showing that nearly 6,500 pharmaceutical crime incidents were recorded in 2021, ranging from innovator drugs to generics, and from antimalarials to blood pressure medicine to vaccines. What packaging and labeling strategies are pharma/biotech companies using to tackle this?

10. Leveraging An Application Managed Services (AMS) Provider For Pharma/Biotech Serialization Systems 11/16/2023

    With the expansion of serialization requirements, including the need for Drug Supply Chain Security Act compliance, many pharma/biotech companies are turning to serialization technology systems to help them manage those specifications. This article shares the key benefits of leveraging an application managed services (AMS) provider as well as key considerations for selecting a provider.