Fdanewsdrugdailybulletin

June 26, 2017

Vol. 14 No. 122

View Archived Issues

Sign Up Now

FDA Draft Guidance Calls for Early Correspondence to Speed ANDA Review

FDA’s new guidance will shorten review timeline. Read More

Pediatric Cancer Panel Recommends Moving Away from Single-Agent Studies

Sponsors must consider if the drug is used as a single agent or part of a combination therapy. Read More