pharmaphorum1d
Unravelling the impact of ICH E6(R3) on Good Clinical Practice
Good Clinical Practice (GCP), the bedrock of ethical and ... However, like other aspects of drug development, it is evolving. The International Council for Harmonisation of Technical Requirements ...
Pharmaceutical Technology on MSN4d
FDA approves IND application for Everest’s cancer vaccine
EVM14 is the first messenger RNA (mRNA) therapeutic vaccine developed internally by the company to gain this approval. Its ...
Clinical Trials Arena on MSN3d
FDA aligns with Imunon’s Phase III trial protocol for ovarian cancer treatment
Imunon is initiating sites for the trial and collaborating with investigators to commence participant enrolment.
pharmaphorum1d
Don’t sweat an FDA sIRB mandate in clinical research – It’s good news for everyone
By the end of 2024, the US Food and Drug Administration ... requiring sIRB review. It’s good news for everyone, even if it represents a shift in control from clinical trial sites to the industry ...
UUHC Health Feed14d
Cancer Clinical Trials
Clinical research is overseen by the FDA to ensure trials are designed, conducted, analyzed, and reported according to federal law and good clinical practice regulations. Clinical trials at Huntsman ...
Yahoo Finance1mon
EXCLUSIVE: After FDA Response, Adial Starts Manufacturing Clinical Supplies For Upcoming Phase 3 Program Of Lead Candidate For Alcohol Use Disorder
On Tuesday, Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) announced a positive response from the U.S. Food and Drug Administration ... Adial is manufacturing clinical supply materials in preparation ...