Replies to post #35798 on Biotech Values

[DewDiligence]

CDER slides on the new initiative for generic drugs:

http://www.fda.gov/cder/present/galson_OGD2006.pdf

Note the mention of citizen petitions in slide #4. An ANDA that has an outstanding citizen petition is not eligible for priority review under the new rules, which is a very wide loophole.