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Jun 92 min read

USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission

The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...

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Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Jul 19, 20211 min read

Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss

Guidance document Packaging for Human Medicinal Products HMV4 This guidance document explains how primary and secondary packaging...