http://www.camargoblog.com Drug Development Comments - Focused on 505(b)(2) Wed, 10 Mar 2010 19:57:01 +0000 http://backend.userland.com/rss092 en Effective March 15th, the FDA's Division of Anesthesia, Analgesia, and Rheumatology Products is being reorganized. This reorganization is part of some other reassignments announced yesterday (3/09/2010) by the FDA. The "R" part – Rheumatology, will move to the Division of Pulmonary and Allergy Products, which will be renamed the Division of ... http://www.camargoblog.com/2010/03/10/fda%e2%80%99s-daarp-is-now-daap-dpap-is-now-dparp/ Exalgo, hydromorphone extended release tablet was approved March 1, 2010. I waited a couple of days to see if it was approved under 505(b)(1) or 505(b)(2). At this writing, we don't know. We have previously detailed in this blog the regulatory approval saga for this drug. When we last ... http://www.camargoblog.com/2010/03/03/exalgo-approved/ Another example of the importance CMC was reported in January. Warner Chilcott plc received a complete response letter from the FDA. The "low dose" oral contraceptive NDA was the file in question. The FDA inspection of the third-party drug substance manufacturing facility and control testing laboratory used to ... http://www.camargoblog.com/2010/03/02/do-not-neglect-your-third-party-drug-substance-manufacturer-2/ On February 19th, 2010, FDA published a proposed rule in the Federal Register to revise 21 CFR §§ 16, 58, 71, 101, 171, 190, 312, 511, 571 and 812 to require Sponsors of the various impacted regulatory applications to file a report with FDA providing specific information when someone "has ... http://www.camargoblog.com/2010/03/02/proposed-fda-rule-would-make-sponsors-more-responsible-for-data-integrity-way-more-responsible/ At GPhA last week, one of the CEO's on an industry panel said that big pharma spent more on DTC (direct-to-consumer) advertising than on R&D.  Clearly, generic companies don't like this promotional activity, but I was skeptical of the facts.  A quick Google of DTC costs brought an article in the New ... http://www.camargoblog.com/2010/02/23/spending-on-dtc-ads/ I attended the Annual GPhA meeting this past week.  This event is attended by the CEO's and other top brass of most of the major generic pharmaceutical companies. This year was highlighted by a presentation from the FDA Commissioner, Dr. Margaret Hamburg.  In her remarks, Dr. Hamburg admitted to a need ... http://www.camargoblog.com/2010/02/20/generic-approvals-taking-longer/ In the past two months, two appellate courts, the Fifth Circuit and the Eighth Circuit have handed down decisions which essentially state that generic pharmaceutical companies can be sued in state courts for failure-to-warn regarding serious side effects, where the generic companies had conformed their labeling to that of the ... http://www.camargoblog.com/2010/02/11/can-and-should-anda-labeling-differ-from-the-rld/ John Jenkins, Office of New Drugs Director, remarked on the low rate (30 percent) of firstcycle approvals for standard review applications ('The Pink Sheet,' Dec. 7, 2008). He attributed the low approval rate in part to the submission of applications that require amendments, often because the original submissions were incomplete ... http://www.camargoblog.com/2010/02/11/roches-actemra-approved-for-ra-after-year%e2%80%99s-delay/ Tuesday, February 2nd, Teva Pharmaceuticals announced that the FDA will review its new biologic license application (BLA) to sell a biotechnology medicine, Neutroval, to boost white blood cells, which is "similar" to Amgen Inc's Neupogen®(filgrastim). The new product is already marketed as TevaGrastim in Europe. There is a regulatory pathway ... http://www.camargoblog.com/2010/02/08/news-on-the-biosimilar-front/ As we have noted in this blog on several occasions, under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all new drug applications for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration are required to contain an assessment of the safety ... http://www.camargoblog.com/2010/02/05/pediatric-assessments-in-drug-development-timing-in-europe-vs-us/