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King & Spalding

FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities

King & Spalding on

On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics (Draft Accelerated Approval...more

Knobbe Martens

China Drug Administration Proposes Pharmaceutical Data Protection Guidelines

Knobbe Martens on

On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...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

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