Camargo is fully prepared to create, submit and manage the review of an NDA, either 505(b)(1) or 505(b)(2). Generally, we submit the NDA electronically, so we’re submitting an eCTD.
1. An individualized secure shared website for Camargo and the Client’s project is created for document control. A folder structure is set up according to the Client’s [...]
Archive for the '505(b)(2) Process' Category
505(b)(2) NDA Preparation Process
Published January 26th, 2010 in 505(b)(2) Process and How to:. 0 CommentsDoes Europe have a pathway for approval of drugs analogous to the FDA’s 505(b)2 pathway?
Published November 4th, 2009 in 505(b)(2) Process and How to:. 0 CommentsAs readers of this blog will know, a 505(b)(2) application is a US NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Under the right circumstances, either a new chemical entity [...]
505(b)(2) Submissions: No RLD
Published October 28th, 2009 in 505(b)(2) Issues and 505(b)(2) Process. 1 CommentTwo weeks ago (10/14/09) I had the pleasure to present at the Drug Repositioning Summit in Boston. I started my talk by asking the audience if a 505(b)(2) application required a Reference Listed Drug (RLD). Most replied affirmatively. My talk was on 505(b)(2)’s without an RLD.
Let’s take a look at the regulation itself:
Notice that there is no mention [...]
Comparability Protocols
Published September 10th, 2009 in 505(b)(2) Process and CMC Issues. 0 CommentsWhat do you need to do when you need to change suppliers or manufacturing sites? Among the many choices is a formal FDA Comparability Protocol. Our VP CMC, Lynn Gold explains.
Advance planning can improve the possibility of FDA accepting your proposed change. One alternative that can streamline the process of change and add clarity to the requirements involves [...]
Today I conducted an audio conference entitled: FDA banning DESI Drugs-Submissions Strategies to Keep Yours on the Market. I know, a bit aggressive, but it’s also a crowded market. Judging from the questions, most attendees are current DESI producers looking to gain knowledge of the pathway to FDA approval. As we have tracked in this [...]
Test Specifications for Stability Studies
Published September 1st, 2009 in 505(b)(2) Process, CMC Issues, How to: and Outsourcing. 0 CommentsPivotal stability programs that are used to generate stability data for NDA submissions are different than research stability programs used to design the drug product, explore packaging configurations, etc. This is common sense, but we have seen instances of pivotal stability programs that have been performed for clients with no defined specifications. A stability protocol [...]
BDSI’s buccal fentanyl 505(b)(2) NDA approved
Published July 28th, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsBioDelivery Sciences International received FDA approval of its 505(b)(2) NDA for buccal fentanyl on July 16, 2009. Most notable about this approval is the first REMS (Risk Evaluation and Mitigation Strategies). The FDA cautioned that this REMS shouldn’t be used as an example for other opioid products. The reason is that the product is indicated [...]
Make the Most of Your Interactions with the FDA: FDA Meeting Requests
Published June 29th, 2009 in 505(b)(2) Process. 0 CommentsAny 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 to [...]
Linking Preclinical (Safety), Clinical (Efficacy) and CMC (Quality) Development Activities
Published June 26th, 2009 in 505(b)(2) Process and CMC Issues. 0 CommentsCamargo 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 [...]
FDA warns P&G over use of Drug + Vitamin C
Published November 2nd, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsLast Thursday, 10/29/2009, FDA sent P&G a warning letter regarding Vicks DayQuil Plus Vitamin C and Vicks NyQuil Plus Vitamin C. The FDA takes the position that these two products are unapproved drugs because they combine a (OTC) drug and a dietary supplement. The relevant passage from the FDA warning letter is:
Notwithstanding your attempt to market each [...]