I have added a new page to this blog to track 505(b)(2) approvals. Please note the tab named Scorecard. It will be organized by calendar year. I am currently catching up on 2009 to date.
Enjoy and give feedback when needed!
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You are currently browsing the Drug Kennel weblog archives for the day Wednesday, July 29th, 2009.
Longer entries are truncated. Click the headline of an entry to read it in its entirety.
Latest
- 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