Before filing an IND, it is desirable (we counsel imperative) to have a pre-IND meeting with the FDA. The goal is to get FDA’s concurrence with the proposed development plan and regulatory submission pathway. The steps for this meeting (known as a Type B meeting) include: Prepare a pre-IND submission package. This package outlines where we [...]
Archive for January, 2008
505(b)(2) – Part 3: Pre-IND submission & meeting
Published January 30th, 2008 in 505(b)(2) Process. 0 Comments505(b)(2) Audioconference January 28, 2008
Published January 22nd, 2008 in Events and How to:. 2 CommentsI have been invited to present an audio-conference entitled : “The FDA 505(b)(2) Drug Approval Process: How to Navigate the Pathway “. The event will take place January 28, 2008 from 2:00 – 3:30 EST. The cost is $349 (I receive no remuneration). The announcement is here.
We are often asked if a 505(b)(2) application always requires a clinical study (i.e., Phase 2 or 3 in patients). The answer is a resounding NO. On January 14, 2008 ADVENTRX Pharmaceuticals announced the successful completion of a bioequivalence study that demonstrated similar blood levels and a “statistically significant reduction in injection site reactions”. The company further [...]
505(b)(2) – Part 2: The Assessment: Timeline, Cash Flows
Published January 16th, 2008 in 505(b)(2) Process. 0 CommentsOnce the clinical development plan is established, the CMC, regulatory and medical communication plans can be matched up. We use MS Project to develop a high-level overall plan. MS Project then can be used to generate cash flows and Gantt charts. This information can be used by the sponsor to determine if the project is financially feasible. [...]
PDUFA 2008 – New Submisison Fees for 505(b)(2) Applications
Published January 10th, 2008 in 505(b)(2) Issues and Events. 0 CommentsFDA announced that for 2008 the full application fee for a 505(b)(2) that requires a clinical study will be $1,178,000. In addition, the establishment fee is $392,700 and the product fee is $65,030. Small businesses (defined as entities, including affiliates, with less than 500 employees) may request a waiver of the PDUFA review fee for [...]
FDA takes action against compounding pharmacies’ estriol-containing hormone products
Published January 10th, 2008 in News Commentary. 0 CommentsOn January 7, 2008, the FDA issued warning letters to several compounding pharmacies (example) advising them stop compounding hormone products contain estriol, an unapproved new drug. This activity has been going on since the mid-1990′s, popularized by the actress Suzanne Somer’s books. The general term used by this industry is bio-identical hormone replacement therapy – BHRT. [...]
Oral Sleep-Aid Spray Approved Based on BE/Pharmacodynamic Studies
Published January 29th, 2008 in News Commentary. 0 CommentsNovaDel announced on January 23, 2008 that FDA accepted their 505(b)(2) filing for an oral spray ZolpiMist (TM). The reference listed drug is Ambien(R) Tablets. The press release indicated that the filing was based on “two randomized, open-label, dose-ranging studies comparing ZolpiMist(TM) with Ambien(R) tablets in young and elderly healthy volunteers. Both studies compared the pharmacokinetics [...]