According to a blog post on fdalawblog...
Yesterday, the U.S. Senate passed S. 3560, the “QI Program Supplemental Funding Act of 2008.” Section 4 of the bill would amend the FDC Act to add new subsection 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old” antibiotics.
The details can be read here.
2 comments:
Does anyone have a list of the antibiotics affected by this potential change?
If you haven't found it yet,look in Federal Register Docket No. 99N-3088.
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