Search for: "Strength v. U.s.*" Results 381 - 400 of 454
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28 Oct 2010, 1:59 pm by Bexis
  That none of them did is a sign of the strength of the preemption doctrine in the medical device field.First, the plaintiffs tried an argument that had prevailed in Wyeth v. [read post]
5 Oct 2010, 7:43 pm by David
§ 48 after the Supreme Court’s decision in United States v. [read post]
13 Sep 2010, 11:02 am by FDABlog HPM
§ 320.22 apply to vancomycin HCl capsules, says ViroPharma: [V]ancomycin capsules are not an injectable, topical or oral solution, or inhalation drug product (§ 320.22(b)); vancomycin is not a DESI drug (§ 320.22(c)); vancomycin capsule ANDAs do not seek approval of a different strength of a drug product that has already been approved (§ 320.22(d)(2); in vitro bioequivalence methods for vancomycin have not, to ViroPharma's knowledge, been shown to be… [read post]
22 Jun 2010, 6:28 pm by Roberto M. Suárez
The legal, business, and scientific communities eagerly await the Supreme Court’s ruling in Bilski v. [read post]
17 Jun 2010, 10:08 am by Seth Borden
The United States Supreme Court today handed down its long-awaited decision in New Process Steel L.P. v. [read post]