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Sharan Murugan
- Jun 9
- 2 min
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The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...
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Sharan Murugan
- Apr 4
- 2 min
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Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...
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Sharan Murugan
- Jul 19, 2021
- 1 min
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...
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