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 to [...]
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You are currently browsing the Drug Kennel weblog archives for the day Monday, June 29th, 2009.
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- Proposed FDA rule would make Sponsors more responsible for data integrity - way more responsible
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- Roche’s Actemra Approved For RA After Year’s Delay
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 for [...]