05/18/2015
Federal Register Notice: FDA is making available draft recommendations for preparing a Study Data Standardization Plan. It is refe...05/18/2015
Federal Register Notice: FDA is making available a draft guidance entitled Adaptive Designs for Medical Device Clinical Studies; D...05/18/2015
Federal Register Notice: FDA is making available a draft guidance for industry entitled Patient Preference Information — Sub...12/19/2014
Federal Register Notice: FDA will hold a public conference 3/18-19/15 entitled “Serious Drug-Induced Liver Injury (DILI): Th...12/19/2014
Federal Register Notice: FDA’s proposed collection of information, “Certification To Accompany Drug, Biological Produc...12/19/2014
Federal Register Notice of public meeting: FDA will hold a public meeting 4/2 on patient-focused drug development for breast cance...12/18/2014
Federal Register Proposed rule: FDA is proposing to amend its prescription drug and biological product labeling regulations to req...12/18/2014
Federal Register Notice: FDA’s proposed collection of information, “Guidance for Industry: Fast Track Drug Development...