Search


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The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...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


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Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...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


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
4 views
0 comments