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12 Jun 2012, 6:37 am by Kate Fort
Order Complaint-FDC Brief Complaint-tribal court Ex Parte TRO – tribal court Motion to Withdraw TRO-tribal court   [read post]
22 Aug 2019, 6:56 am by Arina Shulga
  These funds were invested into start-ups incubated by Frost Data Capital, LLC ("FDC"), an entity wholly-owned by Mr. [read post]
14 Feb 2011, 2:11 am by FDABlog HPM
The February 1, 2011 warning letter to Tennessee Scientific, Inc/Scientific Formulations LLC bears only the signature of the FDA District Director. [read post]
26 Apr 2011, 1:56 pm by FDABlog HPM
 Source: Leerink Swann LLC “RTFs Suggest FDA Filing Decisions May Have Become More Meaningful Events,” April 25, 2011. [read post]
15 Sep 2011, 4:01 pm by FDABlog HPM
Scenic View Dairy, LLC, et. al., the government prevailed on summary judgment in an injunction action against dairy farms alleged to market cows bearing unlawful drug residues. [read post]
11 Aug 2010, 11:14 am by FDABlog HPM
  Finally, FDA argues that the Regenexx Product is adulterated and misbranded under the FDC Act. [read post]
28 Jun 2017, 7:31 pm by FDABlog HPM
The statute (FDC Act 744B(g)(5)) would also be amended to include certain penalties for failure to pay the new ANDA Holder Program Fee: (A) IN GENERAL. [read post]
11 Aug 2011, 5:25 pm by FDABlog HPM
The MMA also added an almost identical counterclaim provision at FDC Act §505(c)(3)(D)(ii) applicable to 505(b)(2) applications. [read post]
1 Dec 2011, 3:36 am by SHG
© 2011 Simple Justice NY LLC. [read post]
10 May 2011, 10:40 am by FDABlog HPM
District Court for the District of Columbia ruled in FDA’s favor in a case filed last July by Graceway Pharmaceuticals, LLC (“Graceway”) stemming from the Agency’s January 2010 denial of a Graceway citizen petition and approval of a generic version of Graceway’s ALDARA (imiquimod) Cream, 5%. [read post]
25 Aug 2010, 12:37 am by Kelly
USPTO – Briefing schedule update (Patent Docs) US: Patent expiration, pediatric exclusivity, and generic drug approval – Some interesting tensions between the FDC Act and patent law (FDA Law Blog) Products Androderm (Testosterone) – US: False marking complaint based on Watson’s marking of its Androderm products: Promote Innovation LLC v. [read post]