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The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...

Sharan Murugan
Jun 9, 20242 min read
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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Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Sharan Murugan
Apr 4, 20242 min read
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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...

Sharan Murugan
Jul 19, 20211 min read
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