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Smart & Biggar

Health Canada updates Guidance Document: The Management of Drug Submissions and Applications

Smart & Biggar on

On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications....more

Jones Day

FDA Establishes Electronic Privacy, Security, and Reliability Criteria for Clinical Trial Records

Jones Day on

In March 1997, the Food and Drug Administration ("FDA") published a final rule, codified in 21 CFR Part 11 ("Part 11"), establishing the privacy, security, and reliability criteria for electronic records and electronic...more

Kelley Drye & Warren LLP

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

Kelley Drye & Warren LLP on

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

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