As part of its efforts to capture patients’ perspectives, the U.S. FDA is considering establishing an “Office of Patient Affairs” that would be tasked with coordinating patient engagement across the agency. The move to create the office would be part of the agency’s efforts to offer a single entry point to the Agency for the patient community and patient stakeholders. (Regulatory Focus)
Biocom program “Zika Virus and Emerging Diseases” highlights importance of public-private collaboration
by Marie Jung BioCom’s October 13th Breakfast Meeting on “Zika Virus and Emerging Diseases” was not one to be missed, but in case you had something else going on, Clinical Currents is here to update you. The talk was sponsored by DLA Piper, and was led by Karen Midthun, M.D., Read more
Investigational new drug application (IND) sponsors communicating with the US Food and Drug Administration (FDA) during the various drug development phases now will have a new set of best practices to consult with prior to their meetings thanks to draft guidance released by FDA on Friday. (Regulatory Focus, Regulatory Affairs Professionals Society)
The FDA issued its expected guidance on rare disease drug development in late August, 2015, and public responses are due in October. Behind the scenes is the buzz of collaboration between patient advocacy groups and drug developers as we analyze, exchange thoughts, and prepare our responses to this important document. (Geeks Talk Clinical)
Product Development Under the Animal Rule. October 27, 2015. Final. CDER
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs. August 5, 2015. Draft, Revision II. Advertising.
Considerations for the Design of Early-Phase Trials of Cellular and Gene Therapy Products; Guidance for Industry. Final. June 9, 2015. CBER