Jennifer Inman-Cartwright emailed me today saying that she sat in on a conference call with the Children’s Cancer Caucus – Advocacy (CCCA) where the topic was the FDA and orphan drug issues.
She forward the slide presentations which you can view and download.
The first presentation was by James E. Valentine, MHS, JD Candidate at the FDA Office of Health and Constituent Affairs. He discussed the OHCA mission and outlined a few of their programs. This is an area that we will be getting involved in so I recommend that everyone takes a look at this. View and download the PDF here.
The second presentation was by Dr. Gayatri R. Rao, Director of the FDA’s Office of Orphan Products Development (OOPD). In this presentation, Dr. Rao discusses two upcoming FDA Workshops both which are open to the public in-person (in Maryland) or via webcast in the comfort of your home or office. The meetings will be held on January 6, 7, and 8th and run from 9am – 5pm. View and download the PDF here.
If you have interest in attending these workshops, December 20th is the deadline for registering for an in-person seat, and for those who wish to attend via webcast, you just need to dial in on those days.
Information on the workshops can be found on the FDA website page: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm367656.htm