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23 Apr 2007, 8:43 am
Andrx Pharmaceuticals, Inc.) , Nos. 04-1562, 04-1563 & 1589 (Fed. [read post]
30 Mar 2011, 6:17 am by Larry Ribstein
When the drug was finally approved, in July 2010, Mr. [read post]
21 Aug 2009, 9:38 am
Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research. [read post]
31 May 2012, 2:59 am
Food and Drug Administration has determined.A citizen's petition filed with FDA by the Washington D.C. [read post]
22 Jul 2020, 5:59 am
Gagne, Olshan Frome Wolosky LLP , on Wednesday, July 22, 2020 Editor's Note: Kenneth M. [read post]
25 Jun 2013, 9:51 am by Sheppard Mullin
Subsequently, Actavis, Inc. and Paddock Laboratories filed separate Abbreviated New Drug Applications pursuant to the Hatch-Waxman Act (21 U.S.C. [read post]
6 Feb 2007, 11:56 am
For the following reasons, we affirm the district court's ruling.In USA v. [read post]
25 Jan 2019, 12:00 am by David Lopez
During the conference, Gottlieb also commented on the FDA’s goal to increase biopharma competition in the generic drug market to help lower costs. [read post]
14 Apr 2010, 11:06 am by Will
It’s not a drug or device case, but a recent per curiam from the 7th Circuit (with a panel that includes McConnell’s BFF Posner) recently caught our eye. [read post]
25 Jul 2012, 5:56 pm
The first bellwether trial in those cases is set for Feb 5 and involves a woman’s claim that one of Bard’s Avaulta implants injured her. [read post]