Another example of the importance CMC was reported in the news today. Warner Chilcott plc received a complete response letter from the FDA. Their “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 support the application [...]
Archive for January, 2010
Do Not Neglect Your Third-Party Drug Substance Manufacturer
Published January 29th, 2010 in Uncategorized. 0 CommentsMorphine Sulfate Oral Solution – Roxane is First across the 505(b)(2) Finish Line
Published January 27th, 2010 in Uncategorized. 0 CommentsAlthough morphine sulfate oral solution has been used for many years in pain management, it had never been approved by the FDA. As part of their ongoing unapproved drugs initiative, the FDA announced on March 30, 2009 that it was taking enforcement action against Roxane and 6 other firms selling morphine sulfate oral solution. [...]
505(b)(2) NDA Preparation Process
Published January 26th, 2010 in 505(b)(2) Process and How to:. 0 CommentsCamargo 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 [...]
FDA is trying to remove unapproved new drugs from the market. This past year the FDA approved URL’s colchicine. Previously, FDA announced it was taking action against unapproved colchicine on the market. We have commented on these actions in this blog.
A recent article in Kaiser Health News questions whether the approval of these [...]
Once a new drug application (NDA) has been accepted by the agency for filing, the PDUFA review clock starts. We all know the importance of the shortest time to market. Recently MannKind Corporation issued a press release stating that the FDA will not be able to complete the review of MannKind’s NDA for [...]
Yesterday I presented an audioconference on 505(b)(2) candidate selection. A participant posed the following question:
What if our company is developing a drug product (A) and a competitor is also developing a similar product (A’). Can both be approved?
The way this would normally work at FDA is that it would approve the first product [...]
2009 saw a record number of 505(b)(2) approvals. A total of thirty-three (33) 505(b)(2) NDA’s were approved by FDA in calendar 2009:
23 new formulations
1 New Molecular Entity
5 new combinations of existing drugs
4 drugs already marketed, but without an approved NDA
We track approvals on this blog as they occur (click here to see my entire list [...]
Analytical Requirements for Oral Solutions
Published January 7th, 2010 in CMC Issues and How to:. 0 CommentsAnalytical requirements for the NDA submission of an oral solution to the FDA are very similar to those requirements for any new drug product. The analytical methods that are used for the testing of an oral solution at the NDA stage of development should be fully validated per the ICH guidelines, Q2A and Q2B, now
ICHQ2(R1) [...]
Do not start the New Year off with CMC issues. Take the time to follow-up on your subcontractors before the FDA finds problems and delays submission approval. Pharmaxis Ltd. just found out the hard way that poor oversight of manufacturing and testing subcontractors will be a concern for the FDA. This concern translates into approval [...]
PhRMA Adds New Bio Companies
Published January 11th, 2010 in News Commentary. 0 CommentsThe trend in Big Pharma continues to shift from small molecules to biologics. PhRMA announced that it added seven (7) new members to its roster at the end of the year. The new PhRMA members are Cubist Pharmaceuticals, Inc., Lexington, MA; OSI Pharmaceuticals, Inc., Melville, NY; Alexion Pharmaceuticals, Inc., Cheshire, CT; Ferring Pharmaceuticals, Inc., [...]