FDA continues to remove unapproved DESI products from the market. Generally, it appears that the removals occur when the manufacturing site is inspected and the FDA identifies unapproved products being made. The latest manufacturer to be hit is ANIP Acquisition Company. During an inspection of the firms facilities in Gulfport, MS this past February, the [...]
Archive for September, 2009
More DESI Tannates removed from market
Published September 21st, 2009 in News Commentary. 0 CommentsA Treatment IND is NOT the same as an IND
Published September 14th, 2009 in News Commentary. 0 CommentsIn this blog I seldom quote or provide hyperlinks to press reports because they too often contain misleading information. Yet, today’s DIA web summary contained an article that I just have to correct. The article was a summary of a report on Medpage’s website. The report’s heading is inadvertently correct: “FDA Finds Oral Insulin Spray [...]
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 [...]
Costs keep rising at FDA and for 2010 this is reflected in a 12.7% increase in user fees. The new user fee for a full NDA submission is $1,405,500. The fee for 2009 is $1,247,200. Remember, for the federal government, 2010 starts October 1, 2009.
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 [...]
Biosimilars – An introduction
Published September 30th, 2009 in News Commentary. 1 CommentRelated to the current frantic activity regarding health care in the US, there is a smaller struggle concerning biosimilars that in many ways mirrors the larger health care struggle. Drug products made from small molecules are regulated primarily by the Food, Drug and Cosmetic Act (FD&CA) and through regulations promulgated by the FDA Center [...]