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You are currently browsing the Drug Kennel weblog archives for the day Wednesday, November 25th, 2009.
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- 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
- News on the Biosimilar Front
- Pediatric Assessments in Drug Development: timing in Europe vs. US
505(b)(2) - Giving Thanks
Published November 25th, 2009 in News Commentary. 0 CommentsNo turkey, no Black Friday specials, just a thank you note.
Little did we know that in 1984 Congress would provide for a regulatory pathway that would provide such a cornucopia of beneficial products that we see under development today. US consumers should give thanks for the role drugs play in improving health and extending lives, a [...]