Search for: "FDC, LLC"
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27 Feb 2024, 7:08 pm
Ezra Ventures LLC, 909 F.3d 1367 (Fed. [read post]
12 Aug 2022, 4:24 am
Amniotic Fluid / Amniotic Membrane Tissue Audits, Investigations and Prosecutions are Continuing to Climb in 2022 (August 4, 2022): Over the past year, we have seen a significant increase in the number of Medicare administrative audits, False Claims Act investigations and criminal prosecutions by the Department of Justice (DOJ), related to the billing of allogeneic (harvested from someone else) stem cell products. [read post]
22 Aug 2019, 6:56 am
These funds were invested into start-ups incubated by Frost Data Capital, LLC ("FDC"), an entity wholly-owned by Mr. [read post]
28 Jun 2017, 7:31 pm
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]
10 Nov 2015, 10:41 am
BlueHippo Funding, LLC, No. 1:08-cv-01819 (S.D.N.Y. [read post]
12 Jun 2012, 6:37 am
Order Complaint-FDC Brief Complaint-tribal court Ex Parte TRO – tribal court Motion to Withdraw TRO-tribal court [read post]
1 Dec 2011, 3:36 am
© 2011 Simple Justice NY LLC. [read post]
15 Sep 2011, 4:01 pm
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 2011, 5:25 pm
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]
20 Jun 2011, 7:01 pm
” In Bayer Healthcare, LLC v. [read post]
10 May 2011, 10:40 am
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]
2 May 2011, 5:45 pm
” The second case, Laser Pharmaceuticals, LLC v. [read post]
26 Apr 2011, 1:56 pm
Source: Leerink Swann LLC “RTFs Suggest FDA Filing Decisions May Have Become More Meaningful Events,” April 25, 2011. [read post]
23 Feb 2011, 10:58 am
” FDC Act § 505(j)(5)(B)(iii) (emphasis added). [read post]
14 Feb 2011, 2:11 am
The February 1, 2011 warning letter to Tennessee Scientific, Inc/Scientific Formulations LLC bears only the signature of the FDA District Director. [read post]
28 Oct 2010, 3:45 pm
., LLC v. [read post]
25 Aug 2010, 12:37 am
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]
11 Aug 2010, 11:14 am
Finally, FDA argues that the Regenexx Product is adulterated and misbranded under the FDC Act. [read post]
22 Jul 2010, 1:11 pm
Brookstone Pharmaceuticals, LLC. [read post]
13 Jul 2010, 12:02 pm
Karst – Although it took a little longer than we expected, late last week, Graceway Pharmaceuticals, LLC (“Graceway”) sued FDA in the U.S. [read post]