We believe that the 505(b)(2) drug development pathway is best used when we can improve the safety and/or efficacy of an existing drug product. We see many opportunities to improve clinical effectiveness, but before trying to prove this in a clinical setting – which is time-consuming and costly, we try to examine the hypothesis using other [...]
Archive for the 'How to:' Category
Role of In Vitro / In Vivo Metabolism Studies in 505(b)(2) Drug Development of Metabolite Products
Published June 8th, 2011 in 505(b)(2) Process and How to:. 0 CommentsKV’s Makena®: A trove of 505(b)(2) Lessons
Published May 16th, 2011 in 505(b)(2) Process, Events and How to:. 0 CommentsOn February 3, 2011 Hologic, Inc. (subsequently sold assets to KV Pharmaceuticals) received 505(b)(2) approval of Makena®, its 17α-hydroxyprogesterone caproate injection (17P) to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The subsequent announcement that the price would be set at $1500 [...]
User Fee Waivers: What is an Affiliate? New Guidance Issued
Published March 10th, 2011 in How to:. 0 CommentsUnder the current PDUFA regulations, a small business can request a waiver of the normal review fees for an NDA if it is the first NDA submitted by the small business. The definition of a small business is fewer than 500 employees. In determining the 500 employee limit FDA also considers the affiliates of the [...]
PDUFA Fee Waiver: Plan Ahead
Published December 20th, 2010 in 505(b)(2) Issues and How to:. 0 CommentsFor an original NDA, whether it is a 505(b)(1) or 505(b)(2), there is a PDUFA fee to be paid at the time of the submission of the application or the FDA will refuse to file it. For a small business ( a company of less than 500 employees) the fee can be waived for its [...]
Pharmacokinetic (PK) Modeling & Steady-State Simulations: Strategic Use in a 505(b)(2) Drug Development Program
Published December 13th, 2010 in 505(b)(2) Process, Formulation Issues and How to:. 0 CommentsSponsors and their investors continue to seek cost efficient ways to meet their financial milestones. Modeling can be used as a cost effective way to estimate the effect of changing an oral product from immediate release to extended release. Modeling avoids the cost of making multiple formulations and performing several multi-arm pharmacokinetic studies. The following [...]
Most of us know that a BA/BE study of a generic can be done without an IND (the exception, called a Bio-IND, is when the drug being studied is cytotoxic or a radioactive labeled drug). In 505(b)(2) drug development we often are studying the BA/BE of a test drug versus an RLD as part of [...]
Why have a Quality Overall Summary for the Quality Module?
Published October 5th, 2010 in CMC Issues and How to:. 0 CommentsThe Quality Module (Module 3 or Chemistry, Manufacturing and, Controls section (CMC)) in the eCTD format serves 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) with [...]
Experience that shows electronic filing of NDA’s, IND’s and ANDA’s helps speed up the review and approval of these applications. Perhaps because of the software cost and extensive training needed some companies still submit paper applications. Effective today, August 1, 2010, the address to submit the paper ANDA is: Office of Generic Drugs (HFD—600) Center [...]
Many drug development projects stem from licensing an invention or product. Agreeing on the cost of the license is critical to the licensee to assure that the project is economically feasible. The licensor is interested in maximizing the value of the invention. How do you arrive at the terms? One handy source to learn how [...]
Target Product Profile
Published May 14th, 2010 in 505(b)(2) Process, CMC Issues and How to:. 0 CommentsToday’s blog courtesy of Lynn Gold, Ph.D. Camargo’s VP of CMC. In any project development program an understanding of the program goal is critical to finding the shortest path to the final result. Generation of a Target Product Profile early in a development program facilitates reaching the goal of a marketed drug product. It provides [...]
