Regulatory Affairs Editorial
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Quality Management Evolves From Function To Culture Of Bio/Pharmaceutical Businesses
10/18/2023
Quality management maturity is an important new trend in the bio/pharmaceutical industry, lauded as the latest evolution in quality management systems and, as recently as September 2023, enshrined in the FDA’s regulatory documents as a defined assessment protocol.
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Opportunities For AI To Assist Cell & Gene Therapy Companies
10/10/2023
Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.
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FDA Introduces Quality Management Maturity Program
9/26/2023
The FDA program described in a new document, CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development, is a next logical step to drive better quality, more predictable outcomes, and supply chain assurance.
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Is Being Competent And Qualified The Same Thing In The GCP World?
9/13/2023
When it comes to Good Clinical Practice principles, the mention of "competence" is underwhelming. Yet, there is plenty of talk about education, training, and experience. Is "competent" and "qualified" synonymous? Does one imply the other? And why does it matter? Kamila Novak of KAN Consulting explores and explains.
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RBQM Adoption: Current Use, Overcoming Barriers, And Anticipating ICH E6 (R3)
9/12/2023
Steve Young, member of Avoca Quality Consortium, PHUSE Working Group participant, and Tufts survey contributor, discusses the findings of the groups’ joint global research study with CluePoints and Price Waterhouse Cooper (PwC), the implications of the upcoming ICH E6(R3) guidelines, and the future of risk-based clinical trial conduct.
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An Overview Of The 9 FDA Special Designations For Pipeline Drugs
9/8/2023
The FDA employs special designations to streamline and incentivize the advancement of drugs addressing medical gaps. Some designations can accelerate FDA timelines for NDAs and BLAs, others may abbreviate the duration of clinical trials. What scenarios or drugs/therapies are best suited for each?
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How To Navigate The EU's New Interim PSA Program
9/1/2023
In the EU, national health technology assessment bodies generally aren't so well equipped to address novel and complex medicinal products. That makes the EMA's interim parallel scientific advice program especially useful for biologic drug developers completing market authorization activities in EU member states.
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5 Best Practices For Responding To FDA Form 483 Inspection Observations
9/1/2023
How you respond to FDA Form 483 observations will determine if they escalate into more serious consequences, such as a warning letter or enforcement action. You don't want that. Follow this 5-step action plan to make sure the findings are properly addressed.
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Patients Need Faster Access To Approved FDA Vaccines. What Can We Do?
8/17/2023
There are times when a significant lag between the FDA approval of vaccines and the Centers for Disease Control and Prevention (CDC) recommendation of those vaccines throws any newly approved vaccines into patient access purgatory. What can vaccine developers do during the clinical trial phase, and what can other stakeholders do, to help influence a shorter lag?
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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.