Comments for Drug Kennel

Comment on REMS or RiskMAP or what? by REMS for 505(b)(2) products? at Drug Kennel

REMS for 505(b)(2) products? at Drug Kennel — Wed, 19 Jan 2011 17:46:23 +0000

[...] a REMS (Risk Evaluation and Mitigation Strategies — for more information on REMS see a previous posting)? The short answer is: of course it does since REMS affects all applications 505j, 505(b)(1) and [...]

Comment on 2010 Activity by 2010 505(b)(2) Approvals at Drug Kennel

2010 505(b)(2) Approvals at Drug Kennel — Thu, 06 Jan 2011 14:01:19 +0000

[...] join everyone else this time of year and develop a list – ours is a list of FDA approvals made under 505(b)(2). As widely reported (WSJ article here) FDA reported that [...]

Comment on Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities by Why have a Quality Overall Summary for the Quality Module? at Drug Kennel

Why have a Quality Overall Summary for the Quality Module? at Drug Kennel — Tue, 05 Oct 2010 13:57:30 +0000

[...] as the backbone of any regulatory submission, an IND or NDA. We have discussed this in a previous blog posting. There is debate about the usefulness of the Quality Overall Summary (QOS or Module 2.3 of eCTD) [...]

Comment on Generic Approvals Taking Longer by FDA Places Hold on all ANDA PAS & CBE Reviews at Drug Kennel

FDA Places Hold on all ANDA PAS & CBE Reviews at Drug Kennel — Mon, 27 Sep 2010 12:01:21 +0000

[...] a blog posting earlier this year, we discussed the then median 26 month ANDA approval time and how it was [...]

Comment on Generic Approvals Taking Longer by Will We Have Generic User Fees? Public Meeting To Be Held. at Drug Kennel

Will We Have Generic User Fees? Public Meeting To Be Held. at Drug Kennel — Mon, 23 Aug 2010 14:55:42 +0000

[...] for ANDA’s in the Office of Generic Drugs has steadily gotten worse over the years, with median review times approaching 26 [...]

Comment on Competition for 505(b)(2) Approvals by Lannettâ€™s Morphine Sulfate Oral Solution: 505(b)(2) or 505j? at Drug Kennel

Lannettâ€™s Morphine Sulfate Oral Solution: 505(b)(2) or 505j? at Drug Kennel — Mon, 23 Aug 2010 14:42:35 +0000

[...] have addressed this situation before in this blog. You cannot have two NDA’s for the same drug [...]

Comment on FDA Advisory Committee to Review Acura’s Oxycodone plus Niacin; Risk/Benefit in Question by Labeling for Abuse-Deterrent Drugs at Drug Kennel

Labeling for Abuse-Deterrent Drugs at Drug Kennel — Thu, 10 Jun 2010 14:43:41 +0000

[...] to get FDA approval (the question of market acceptance is another matter). Thus, a product like we reviewed recently, Acurox®, had three [...]

Comment on FDA Advisory Committee to Review Acura’s Oxycodone plus Niacin; Risk/Benefit in Question by Oxycodone + Niacin Voted Down 19-1 at Drug Kennel

Oxycodone + Niacin Voted Down 19-1 at Drug Kennel — Fri, 23 Apr 2010 12:57:18 +0000

[...] September 2007 « FDA Advisory Committee to Review Acura’s Oxycodone plus Niacin; Risk/Benefit in Question [...]

Comment on Biosimilars – An introduction by Biosimilars or Biodissimilars? at Drug Kennel

Biosimilars or Biodissimilars? at Drug Kennel — Mon, 19 Apr 2010 20:47:45 +0000

[...] On March 19 and 20th the University of Washington School of Pharmacy hosted “The Biosimilars Conference”. This conference prompted some interesting discussions. A good background of the current legal status and issues around biosimilars can be found in the September 30th blog “Biosimilars; an Introduction”. [...]

Comment on Scorecard by 505(b)(2) Approvals at Drug Kennel

505(b)(2) Approvals at Drug Kennel — Fri, 26 Mar 2010 20:24:52 +0000

[...] Scorecard Subscribe RSS Feed-Posts RSS Feed-Comments [...]