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Innovative Drug, Biologic, and Device Development
Insights 21 results
Client Alert
January 9, 2026
FDA Updates General Wellness and Clinical Decision Support Guidance Documents
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December 29, 2025
Medicare and Medicaid Demos Seek to Impose MFN Pricing: An Overview of GENEROUS, GLOBE, and GUARD
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December 19, 2025
President Trump Signs Executive Order to Reschedule Marijuana, Easing Research and Business Restrictions
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November 19, 2025
2026 Physician Fee Schedule Final Rule Changes to ASP Calculation and Reporting Policies and Other Drug Payment Policies
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August 4, 2025
Congressional Crack Down on Hemp Loophole? Significant Changes Loom for Hemp Industry
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June 5, 2025
Administrative, Congressional, and State Interest Signal a Potential Breakthrough Moment for Psychedelics
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June 4, 2025
FDA Issues Two Guidances For the Device Q-Sub Process
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July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
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January 10, 2024
FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time
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January 3, 2024
FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations
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December 21, 2023
FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies