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27 Jun 2012, 5:38 am by FDABlog HPM
  FDA tentatively approved Ranbaxy’s ANDA No. 076953 for generic DETROL Tablets, 1 mg and 2 mg, on September 15, 2005. [read post]
25 Jun 2012, 8:53 pm by FDABlog HPM
(“Stat-Trade”) in a long-running dispute over FDA’s assessment of user fees under the Prescription Drug User Fee Act (“PDUFA”) in relation to the Stat-Trade’s NDA No. 020353 for NAPRELAN (naproxen sodium) controlled-release tablets, 375 mg, 500 mg, and 750 mg, and the Agency’s process for granting waivers for prescription drug user fees submitted by Stat-Trade. [read post]
25 Jun 2012, 11:44 am by Schachtman
  DURATION OF TRIALS Pfizer was ultimately successful in defending the Celebrex litigation on the basis of lack of risk associated with 200 mg/day use. [read post]
31 May 2012, 7:50 am by Vincent LoTempio
I think it's interesting to see who's filing patent claims in the United States.It seems that most patent litigations these days have to do with methods of using computers and Internet social networking sites. [read post]
1 May 2012, 6:59 am by Cathy Moran, Esq.
Judge recommends the NCLC Summary of Rules of Evidence. 803(14) excepts document as record of interest in property. [read post]
26 Feb 2012, 10:39 am by Kevin O'Keefe
It’s in your own self interest as well as the right thing to do. [read post]
26 Jan 2012, 10:05 pm by Jeffrey Richardson
MG Siegler of TechCrunch provides an interesting perspective on Apple's record quarter earnings. [read post]
12 Jan 2012, 10:20 am by Geoffrey Manne
MG Siegler calls this “doublespeak” and seems to think Google violated the antitrust laws by not making SPYW more inclusive right out of the gate. [read post]
12 Jan 2012, 7:50 am by Berin Szoka
MG Siegler calls this “doublespeak” and seems to think Google violated the antitrust laws by not making SPYW more inclusive right out of the gate. [read post]
9 Jan 2012, 6:24 pm by FDABlog HPM
  Of particular interest to us is Plaintiffs’ assertion that “FDA’s designation of Mylan’s 300-mg phenytoin as an RLD gave Mylan the authority to use the [Changes Being Effected (‘CBE’)] process to change its 300-mg phenytoin label,” and that as such, the court should employ the impossibility preemption analysis utilized in the U.S. [read post]
30 Dec 2011, 5:55 am by pete.black@gmail.com (Peter Black)
" asks @dangillmor pjblack.me/tE2N69 interesting difference between mobile and desktop: "'Chlamydia' Most Frequently Searched Health Term On Mobile Devices" pjblack.me/sMnjrI from @Gizmodo: "Once Upon A Time, We Used Radium Condoms For Glow-In-The-Dark Sex"pjblack.me/rp0fD6 this is really interesting: "Blendr Isnt Grindr: Why We Still Dont Have a Straight Hookup App"pjblack.me/vgUIXL /via @ahulse Image via… [read post]
26 Dec 2011, 9:50 am
Several months ago, we reported about the FDA’s interest in more accurate dosing information for children’s Tylenol . [read post]
19 Dec 2011, 2:26 am
This fraud may have occurred if MF Global knew (and it would be interesting to argue how it did not) that it sought to legally borrow from customer funds, knowing that it was de facto insolvent and could not replace the money. [read post]
1 Dec 2011, 2:02 pm by Tom Lamb
., has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application for Vestura(TM) (3 mg drospirenone and 0.02 mg ethinyl estradiol), a generic version of Bayer's Yaz(R) oral contraceptive product. [read post]
1 Dec 2011, 3:58 am by Lawrence B. Ebert
[See Int J Clin Pract. 2009 May;63(5):766-75. ] BUT, there is an interesting difference among the two as to uric acid: serum uric acid levels, which decreased from 6.0 to 5.7 mg/dL in the losartan group and increased from 5.9 to 6.0 mg/dL in the valsartan group (P = 0.001 for between-treatment difference, from Clin Ther. 2001 Aug;23(8):1166-79.]See also New generic version of Lipitor like an early Christmas presentwhich includes:A month’s supply of Lipitor costs… [read post]