戴維·B·克裏索德(David B.雷諾茲煙草公司起訴FDA,DHHS,Kathleen Sebelius,Margaret Hamburg和Lawrence Deyton,以宣告和禁令救濟……
戴維·B·克裏索德(David B.雷諾茲煙草公司起訴FDA,DHHS,Kathleen Sebelius,Margaret Hamburg和Lawrence Deyton,以宣告和禁令救濟……
Ricardo Carvajal - FDA否認了代表Ovos Natural Health,Inc。(“ OVO”)提交的公民請願書,該請願書要求該機構根據FDC法第201(FF)(3)(b)或§301(b)或§301(b)或§301(§301)(ll)承認,同龍作為飲食補充劑中的飲食成分的營銷…
By Kurt R. Karst – It was just yesterday that we commented on how folks in the Hatch-Waxman community have been patiently awaiting FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic …
作者:裏卡多·卡瓦哈爾(Ricardo Carvajal) - 在致總檢察長埃裏克·霍爾德(Eric Holder)的一封信中,參議員帕特裏克·利希(Patrick Leahy)(D-VT)要求美國司法部(“ DOJ”)對其對美國花生公司(“ PCA”)調查的更新更新及其總統斯圖爾特·帕內爾(Stewart Parnell)。根據這封信,FDA…
By Kurt R. Karst – As folks in the Hatch-Waxman community patiently await FDA’s decision on an October 2010 citizen petition (Docket No. FDA-2010-P-0545) requesting that the Agency not approve any ANDA for a generic version of XYZAL (levocetirizine dihydrochloride) with skinny labeling that omits, via …
作者:Riëttevan Laack - 如前所述,2010年12月8日,FDA發表了一項提案,以修改有關健康索賠的臨時最終規則(“ IFR”),該規定涉及心髒血管心髒病的風險和食用植物固醇的風險(請參閱21 C.F.R.§§§101.83)。FDA表示,AS…
By Ricardo Carvajal – Totally Wicked-E.Liquid (“TWI”), an importer and distributor of electronic cigarettes, filed suit to prevent FDA from regulating TWI’s electronic cigarettes as drugs, devices, or combination products, and from barring their importation into the U.S. TWI claims that the nicotine in its product …
彼得·M·賈森(Peter M. Jaensch)和約翰·吉爾伯特(John A.含有偽麻黃堿的過敏產品(“ PSE”)已受到…的約束。
作者:RiëtteVanLaack - 在過去的兩年中,我們注意到FDA和FTC的幾項聯合或協調行動。這些機構同時(此處和此處)向同一製造商發出了自己的警告信,並有幾次FDA和…
By Kurt R. Karst – Late last year, Impax Laboratories, Inc. (“Impax”) filed a Complaint in the U.S. District Court for the District of New Jersey seeking a judgment with respect to U.S. Patent No. 6,911,217 (“the ‘217 patent”). The ‘217 patent is one of four …