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10 Apr 2012, 3:53 pm by FDABlog HPM
  Specifically, FDA stated in the Agency’s decision that “the revision of the Vancocin label to incorporate clinical data that supports and refines labeling regarding already approved conditions of use, does not constitute approval for a condition of use that has not been ‘approved before the date of enactment’ within the meaning of [FDC Act § 505(v)(3)(B)]. [read post]
12 Sep 2022, 5:39 am by Jack Goldsmith
[Jack Goldsmith and I will have an article out about the Dormant Commerce Clause, geolocation, and state regulations of Internet transactions in the Texas Law Review early next year, and I'm serializing it here. [read post]
15 Sep 2016, 10:58 am by Heidi A. Nadel
Still, a number of noteworthy and significant cases argued back in the early spring are still pending after the Court issued orders waiving the 130 day rule, including cases we have written about before: Partanen v. [read post]
1 Apr 2007, 5:19 am
It would be a user right.Originality v. novelty - copyright and patent. [read post]
12 May 2012, 5:15 am by NL
A fluctuating need does not necessarily take a person outside the scope of s.21(1)(a). [read post]
12 May 2012, 5:15 am by NL
A fluctuating need does not necessarily take a person outside the scope of s.21(1)(a). [read post]