Clinical Supply Regulatory Articles
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New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability
6/28/2024
A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.
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Outsourcing And Phase-Appropriate GMP For Clinical Manufacturing Needs
11/20/2023
Appropriate manufacturing and timely delivery of investigational products are essential for the successful execution of clinical trials. This article shares best practices working with CDMOs as well as phase-appropriate GMP of the clinical supply.
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Making Cancer Vaccines Is Complex; New Platform Guidance Could Help
7/3/2024
FDA's draft guidance on platforms is mostly for established, well-characterized modalities, but it also has implications for the emerging area of personalized medicine.
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Vendor/Supplier Management To Maintain A Drug's Safety Profile In End-To-End Supply Chain Planning
8/17/2023
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
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Supplying Complex, Controversial, And Intercontinental Clinical Trials
3/13/2024
Planning a clinical supply strategy for a complicated substance, psilocybin, is tricky. It's even more tricky doing it from the other side of the planet. Here's one company's approach.
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Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products
5/23/2024
FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.
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Quick Takes From Takeda Austria's Annex 1 Rollout
3/25/2024
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
4/10/2024
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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New Initiative Seeks To Back Up ICH's Harmonization Mission
5/3/2024
An inaugural survey revealed that a lack of harmonized regulations slows the advancement of alternative drug modalities and advanced manufacturing technology.
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4 Tips For Successful Collaboration With Your EU Qualified Person
11/8/2019
Engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated challenges.