Regulatory Affairs Editorial
-
New FDA Guidance: Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics
4/21/2023
On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). The move highlights some of the limitations that have been identified with the accelerated approval pathway and provides insight into the rationale for new FDA draft guidance.
-
Congressional Changes For Orphan Drug Approvals?
4/18/2023
Lawmakers are stepping in to increase the number of rare disease and orphan drug experts who sit on advisory committees. As it stands now, advisory committees can include experts who simply have a broad understanding of the overall disease state.
-
New DSCSA Compliance Blueprint Includes FDA & Industry Input
4/12/2023
Pharmaceutical manufacturers, distributors, and pharmacies must all ensure they are ready for the Drug Supply Chain Security Act (DSCSA)'s full implementation starting on Nov. 27, 2023. The Partnership for DSCSA Governance, a public-private partnership, has published a blueprint compiling input from every sector, including FDA, industry, and solution providers.
-
Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
3/27/2023
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
-
Consistent And Clear Terminology, Best Practices Needed To Scale Sensor-Based DHTs
3/24/2023
Sensor-based digital health technologies (DHTs) have been increasingly adopted in clinical research, clinical care, and everyday life, but a lack of clarity regarding usability best practices means that not all of these tools can be successfully implemented at scale.
-
TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability
3/20/2023
There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.
-
Dispelling 4 Common Myths Of Data Quality Governance
3/9/2023
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
-
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
3/7/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
-
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-Based Decisions
2/28/2023
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.
-
Strategic Procurement For Emerging Pharmas & Biotechs
2/27/2023
Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.