Orphan Drug Regulations
oc2011179 OC Orphan Drug 0910-AG72
2011-11-22 2012-02-15
FDA-2011-N-0583-0002 FDA-2011-N-0583-0012
05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2011-N-0583-0002 https://api.regulations.gov/v4/comments/FDA-2011-N-0583-0012
Anonymous Anonymous
Anonymous Anonymous
The proposed rule that I am choosing to comment on is one that is being filed by the FDA that is suggesting changes to be made to the Orphan Drug Regulations that were passed in 1992.  The changes being made are, more or less, being used to clarify almost two decades old language that, if updated, will benefit persons in the U.S. suffering from a rare disease that affects roughly about 200,000 people, such as cystic fibrosis.After careful study of the proposed amendments to what was originally the Orphan Drug Act of 1983, I believe that this was the right move to be made by the FDA.  As technology continues to grow and develop, so should acts such as this, especially if they involve anything within the medical spectrum.  The advances that have been made in medicine since 1983 are vast and when there are regulations in place that deal with specific rare conditions and diseases the only logical step to take would be to review the issues, and amend them as such.  According to the Federal Register, since the Orphan Drug Regulation was published in 92, there have been over 3,350 different requests for orphan-drug designations for these rare diseases and conditions.  I believe that is too high a number of requests to not have put any sort of amendments in place before now, but that is neither here nor there.  The proposed changes will serve well to aid the requests of the individuals who are in need of these exclusive orphan-drugs. Shire comments to the FDA proposed amendment to the orphan drug regulations