The Food and Drug Administration is holding a public hearing on June 29th called "Considerations regarding FDA review and regulation for Articles for the treatment of rare disease." I've attached the file announcing the hearing (see the highlighted Notice near bottom right and on to the next page).
But, they basically want to know if
1. The methods used to regulate all drugs are working for the regulation of rare disease drugs (and if not, what isn't working and they want suggestions)
2.-3. Two questions about devices for rare disease that I think we are less interested in; and
4 If the communication avenues they've established with the public about regulatory review in rare disease is adequate.
You can attend this meeting in person or you can submit a public comment. You can submit comments electronically at www.regulations.gov. You should mention to which "Docket" you are referring--in this case No. FDA-2010-N-0218 and to which question of the four above you are responding.
PPMD is planning to post comments but you are all welcome to submit comments on your own. I can post the PPMD comments here as well--still drafting those. The deadline for submitting comments is May 31st. I think it would be great for the FDA to hear from this community!
These really hit the nails on the head. Do you think there would be any benefit in submitting our own uniquely worded versions of your four main points as comments, including some brief personal stories?