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Let's talk antitrust: Discussing recent cases and emerging competition issues
Recent cases and judgments have shone a light on some emerging themes and trends that companies will want to consider as part of their risk management framework.
Publication | August 11, 2015
Quality metrics are utilized throughout the pharmaceutical industry to monitor quality control systems and processes and to drive continuous improvement efforts in drug development and manufacturing. The U.S. Food and Drug Administration, through a recently-published draft guidance and its corresponding Federal Register notice, is making good on its decade-old promise to create a system in which pharmaceutical manufacturers consistently and reliably produce “high-quality drug products without extensive regulatory oversight.”[1] This guidance offers transparency to industry by painting a clear picture of what the agency is thinking with regard to the use of certain quality metrics for risk-based oversight. Entities that work to internalize this guidance and produce timely, thoughtful reports to the agency that demonstrate highly controlled manufacturing and a robust quality measurement system should see positive results: less frequent agency inspections and greater ability to self-regulate.
The guidance, entitled Request for Quality Metrics, and the forthcoming corresponding public meeting are intended to explain how the agency plans to use quality metrics data to further develop its risk-based inspection scheduling, to identify situations in which there may be a risk for drug supply disruption, to improve efficiency and effectiveness of establishment inspections and to improve the FDA’s evaluation of drug manufacturing and control operations.
Read the full article: Quality metrics may reduce FDA inspections for pharma cos
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Recent cases and judgments have shone a light on some emerging themes and trends that companies will want to consider as part of their risk management framework.
Publication
After a lacklustre finish to 2022 when compared to the vintage year for M&A that was 2021, dealmakers expected 2023 to see the market continue to cool in most sectors, in response to the economic headwinds of rising inflation (with its corresponding impact on financing costs), declining market valuations, tightening regulatory scrutiny and increasing geopolitical tensions.
Publication
On 18 September 2023, the CMA published its Initial Report (Initial Report) on AI Foundation Models (FM), supplemented in April 2024 with the publication of its “Update Paper” focused on potential antitrust risks associated with FMs and a “Technical Update Report” providing more detail on the development on FMs (collectively the “Reports”). Below, we consider these CMA publications.
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