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The Erosion of the Safe Harbor: Strategic Adaptation in the Era of “Label-Plus” Liability and Regulatory Rigor

In the relentless march of pharmaceutical innovation, the once-clear boundaries that protected companies from legal and regulatory pitfalls are now blurring—posing unprecedented risks for industry players. The traditional “safe harbor” provisions, long…

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The Patent Cliff Protocol: Advanced Methodologies for Forecasting Generic Drug Launches and Market Erosion

In the high-stakes world of pharmaceuticals, the looming “patent cliff” is more than just a buzzword — it’s a seismic event that can reshape entire markets overnight. As blockbuster drugs approach the expiration of their patent protections, pharmaceuti…

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