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3.23.26

New FDA Draft Guidance Clarifies Three-Year Exclusivity for New Clinical Investigations

Key Takeaways

Alerts

2.10.26

Congress Reauthorizes the Rare Pediatric Disease Priority Review Voucher Program and Clarifies Orphan Drug Exclusivity

Key Takeaways

Alerts

12.05.25

FDA Issues Updated Guidance on Expanded Access to Investigational Drugs

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Expanded Access to Investigational Drugs for Treatment Use, clarifying how drug developers, physicians, and patients can obtain investigational drugs outside traditional clinical trials.

Alerts

12.03.25

FDA Issued Updated Patient-Focused Drug Development Guidance on Clinical Outcome Assessments

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Alerts

11.13.25

FDA Moves to Streamline Biosimilar Development: Implications for Regulatory Strategy and Clinical Study Design

Executive Summary

Alerts

10.10.25

FDA Releases Three Draft Guidances to Facilitate Development of Cell and Gene Therapies

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Alerts

9.29.25

Clarifying FDA and USDA Jurisdiction over Animal Biological Products

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9.26.25

FDA’s Release of Complete Response Letters Raises Questions Related to Intellectual Property

Executive Summary

Alerts

9.23.25

FDA Announces Rare Disease Evidence Principles to Accelerate Treatments for Ultra-Rare Genetic Diseases

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Alerts

9.05.25

FDA Launches PreCheck and Advanced Manufacturing Technologies Designation Programs to Strengthen U.S. Drug Manufacturing

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Alerts

8.12.25

FDA Requests Public Comment on Incentives and Obstacles to Pediatric Drug Development

Key Takeaways

Alerts

6.24.25

FDA Announces “Priorities for a New FDA” and a New Vouchers Program to Address National Priorities

Key Takeaways