What? More on the Proposed Rule – Just Think How I Feel, but this is the Last Post on the Proposed Rule!

There are so many issues covered by the Proposed 505(b)(2) and ANDA Rule that we can fill a book with the explanations (and we almost have). But we are giving you the Readers Digest condensed version in these posts. Be certain to read the entire Proposed Rule and watch for comments on Regulations.gov to get an idea of which sections will provide more controversy than others.

The Proposed 505(b)(2) and ANDA Rule Continued!

There are certainly some interesting issues that are going to be codified if the Proposed Rule publishes in final the way it is currently written. Many of the proposals are being formalized into the regulations that represent the Agency’s past practice. Here are highlights of a few more of some of these important issues that should be of interest to our readers.