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Transparency › Clinical Trials › Prescription Drugs

Cozen O'Connor

FDA Transparency Push: CRLs Released

Cozen O'Connor on

On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Akin Gump Strauss Hauer & Feld LLP

FDA Opens the Vault on Decision Letters—Releases Wave of Drug and Biologic CRLs

Akin Gump Strauss Hauer & Feld LLP on

This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more

Smart & Biggar

From regulatory flexibility to reimbursement changes, how Canadian regulators and payers are managing the COVID-19 crisis

Smart & Biggar on

UPDATE: The Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 was made on March 1, 2021 and repeals and replaces the Interim Order Respecting Drugs, Medical...more

Smart & Biggar

First judicial consideration of Vanessa’s Law: Health Canada must disclose requested clinical trial data

Smart & Biggar on

In the first case calling upon a court to interpret and apply Vanessa’s Law, the Federal Court has ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic...more

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