Biotech Values

[mouton29]

Two key authorities --

The most important case cited in these pleadings seems to be the Appeals Court decision in Serono Laboratories v. Shalala. Here is a link to a copy of the case, it is a mere 20 pages or so counting footnotes. http://www.fda.gov/ohrms/dockets/dockets/04p0231/04p-0231-c000001-Exhibit-33-vol4.pdf

The case is cited by both sides on what appears to be the key substantive issue -- whether the FDA could consider or require immunogenicity testing. The key argument by SNY is that the case and law permit the FDA to consider such testing if voluntarily submitted but that the FDA may not require such testing.

The even more basic authority is section 505 itself, available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.92