Newsletter - April 18, 2024
FDA’s New Center for Clinical Trial Innovation: Would it Help the Sponsors?
Since the publication of the Critical Path Initiative over two decades ago which included smart trial designs, the FDA has introduced several innovative clinical trial designs to improve clinical trial conduct and expedite new drug developments. However, the adoption of those non-conventional designs has...Read More
Lily’s Legal Woes Due to Compounded Copies of Its Blockbuster Drug
Eli Lily has been trying to rein in compounding pharmacies from selling compounded versions of its super blockbuster anti-obesity drugs for more than a year now, unsuccessfully, and in the process establishing precedence for the rights of such unauthorized legal versions of approved drugs that would have...Read More
FDA’s New Center for Clinical Trial Innovation: Would it Help the Sponsors?
Since the publication of the Critical Path Initiative over two decades ago which included smart trial designs, the FDA has introduced several innovative clinical trial designs to improve clinical trial conduct and expedite new drug developments. However, the adoption of those non-conventional designs has...Read More
Lily’s Legal Woes Due to Compounded Copies of Its Blockbuster Drug
Eli Lily has been trying to rein in compounding pharmacies from selling compounded versions of its super blockbuster anti-obesity drugs for more than a year now, unsuccessfully, and in the process establishing precedence for the rights of such unauthorized legal versions of approved drugs that would have...Read More
