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HLB Completes application for Pre-NDA Meeting with FDA
HLB announced to the FDA that it has completed the application for the Pre-NDA Meeting for Riboceranib's new drug approval. The company explained that the meeting will take place in mid-October. Ahn Ki Hong, vice president of HLB, said: "For the preparation of pre-NDA meeting, A task force team with consisting key employees who participated in the global phase 3 of Rivoceranib and FDA experts from Covington, a US law firm specialized in drug approval, is already in place" and said "Along with the preparation of submitting main contents that will be discussed at the meeting, practical work to maximize the chance of success of the final objective (NDA) will proceed step by step Within mid-September."
The meeting discusses the effectiveness, safety results and data analysis strategies for the purpose of improving the review efficiency when applying for the NDA. The objective is to increase the possibility of approval of a new drug and the efficiency of document examination.