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You are currently browsing the Drug Kennel weblog archives for the day Wednesday, February 3rd, 2010.
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- FDA Removes Unapproved Nitroglycerin Tablets
- FDA’s Determination of Vyvanse as NME Upheld
- FDA’s DAARP is now DAAP, DPAP is now DPARP
- Exalgo Approved
- Do Not Neglect Your Third-Party Drug Substance Manufacturer
- Proposed FDA rule would make Sponsors more responsible for data integrity - way more responsible
- Spending on DTC Ads
- Generic Approvals Taking Longer
- Can and Should ANDA Labeling Differ from the RLD?
- Roche’s Actemra Approved For RA After Year’s Delay

It’s Budget Time at the FDA!
Published February 3rd, 2010 in News Commentary. 0 CommentsIn a time where there are going to be government spending caps and cuts, the Administration is proposing a 23% increase in FDA’s 2011 budget (see pages 19-21). Some of this additional money is proposed to come from new fees on food facilities ($220 million) and generic drug makers ($38 million in user application fees [...]