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16 Mar 2010, 6:29 pm by Mark Zamora
§§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. [read post]
29 Aug 2010, 9:40 pm by CAPTAIN
There are a large numbers of judges up for reelection in 2012, some of them will be aged out and others will retire, simply deciding not to run for reelection.Here is the list**:CIRCUIT COURT54 Arzola, Antonio68 Blake, Stanford66 Brown, Joel22 Cardonne Ely, Gisela56 Dennis, Maria Espinosa29 Echarte, Jr, Pedro P.13 Fernandez, Jose L.24 Glazer, Mindy S.60 Gross, Maynard A31 Korvick, Maria Marinello48 Lando, Maxine Cohen15 Langer, Lester49 Leban, Mark King14 Lederman, Cindy S.61 Leesfield, Ellen78… [read post]
16 Apr 2010, 6:13 am by VALL Blog Master
CondonMichelle Gernhardt I’d also like to thank those who served VALL as committee chairs or members, and in administrative positions:Evelyn CampbellNancy LoewenbergIsabel PaulVictoria LevyCathy PalombiJane BaughTeresa SchmidCharles J. [read post]
1 Oct 2007, 5:17 am
Thanks to the FDA Blog for pointing out the FDA's letter requesting comment on 180-day exclusivity forfeiture and Orange Book patent "delisting" issues concerning at least one ANDA submitted to the Agency containing a paragraph IV patent certification invloving a generic version of Bayer Pharmaceuticals' PRECOSE (acarbose) tablets:Under changes made to the FDC Act by the 2003 Medicare Modernization Act ("MMA"), generic applicants that are "first applicants"… [read post]