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Apr 42 min read

USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Aug 2, 20221 min read

USFDA Guidance: Electronic Submission of Expedited Safety Reports From IND- Exempt BA/BE Studies

Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...

Oct 3, 20211 min read

USFDA’s drafts “Investigator Responsibilities–Safety Reporting for Investigational Drugs & Devices

The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting...