Search
Sharan Murugan
Nov 162 min read
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
This USFDA draft guidance" Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutic s" , issued on 15 November 2024, offers...
14 views0 comments
Sharan Murugan
Jul 32 min read
ICH Guidance: M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
FDA (FDA or Agency) has announced the availability of a draft guidance for the industry called “M14 General Principles on Planning,...
22 views0 comments