Any meeting with the FDA is critically important to Sponsors. We all know that a tremendous amount of time and effort goes into planning for these meetings. But even before this step the decision to ask for a meeting and the contents of the meeting package should be carefully considered. Typically, a meeting is requested [...]
Archive for June, 2009
Make the Most of Your Interactions with the FDA: FDA Meeting Requests
Published June 29th, 2009 in 505(b)(2) Process. 0 CommentsLinking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities
Published June 26th, 2009 in 505(b)(2) Process and CMC Issues. 1 CommentCamargo is often called on to write and/or assemble NDAs. When we get to prepare an NDA from the beginning, all of the information builds and the resulting ‘story’ is easy for the FDA to understand. Often we are retained to write portions and just insert portions written by third parties. Gaps can ensue. Lyn [...]
ANDA Suitability Petition vs 505(b)(2)
Published June 12th, 2009 in 505(b)(2) Process and ANDA's. 0 CommentsI was honored to be invited to speak at the FDA-OCRA 12th Annual Educational Conference in Irvine California on June 10, 2009. I was asked to discuss and compare the 505(b)(2) and ANDA Suitability Petition. I thought I should share this topic with the readers of this blog. Why make the comparison between an ANDA [...]
Electronic filing of eCTD INDs
Published June 9th, 2009 in 505(b)(2) Process and How to:. 0 CommentsAs large amount of documentation and data are required in IND submissions, the Electronic Common Technical Document (eCTD) format is a wise choice for the submission of INDs to the FDA. Camargo’s experience with filing INDs in the eCTD format includes a very recent eCTD IND application accepted by the FDA’s Division of Anesthesia, Analgesia [...]
Writing and submitting electronic 505(b)(2) INDs
Published June 8th, 2009 in 505(b)(2) Process and How to:. 0 CommentsAny use of a drug product not previously authorized for marketing in the United States first requires submission of an Investigational New Drug Application (IND) to the FDA. To date, the FDA accepts IND submissions in the ‘old format‘ and in the Common Technical Document (CTD) format. The CTD is maintained by the International Conference [...]
Risk Evaluation Mitigation Strategy (REMS) for long-acting opioids
Published June 4th, 2009 in 505(b)(2) Process, Formulation Issues and News Commentary. 0 CommentsCamargo is working with several clients in developing better treatments for pain. Unfortunately, the active substances that supress pain also can be abused. The FDA and DEA are trying to find ways to allow access to these medicines while imimizing the inherent risks of drug abuse. In order to properly advise clients, Camargo attends various [...]
Melphalan – New 505(b)(2) Orphan Designation
Published June 4th, 2009 in News Commentary. 0 CommentsDelcath Systems Inc. announced that the FDA has granted an additional orphan designation for melphalan for the treatment of neuroendocrine tumours metastatic to the liver. Delcath uses a proprietary system they call the Percutaneous Hepatic Perfusion (PHP) System to deliver high doses of existing drugs directly to the site of the tumor. Melphalan was first [...]
Cheerios® – venerable breakfast cereal or…drug? Last month the FDA issued a warning letter to General Mills CEO Ken Powell, informing him that the cholesterol-lowering claims on the Cheerios label transformed it from food product to unapproved drug. The Food and Drug Administration Modernization Act of 1997 allows for certain authoritative health claims to be [...]
A reader pointed out that I have never defined DESI drugs, despite several posts that contained references to them. DESI drugs are a great source for 505(b)(2) development since many will qualify for 5 years data exclusivity. Once upon a time…. In 1938 the FD&C Act was established that required that drugs be proven safe before [...]
ADVENTRX restarts 505(b)(2) development
Published June 29th, 2009 in News Commentary. 0 CommentsToday June 29, ADVENTRX Pharmaceuticals announced plans to use their recent financing to finish the development of ANX-530 (vinorelbine emulsion) and submit a 505(b)(2) NDA by the end of the year. Careful readers of this blog may remember a January 2008 posting citing ADVENTRX ANX-530 as an example of where a single pk study might be sufficient [...]