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You are currently browsing the Drug Kennel weblog archives for the day Tuesday, July 28th, 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
BDSI’s buccal fentanyl 505(b)(2) NDA approved
Published July 28th, 2009 in 505(b)(2) Process and News Commentary. 0 CommentsBioDelivery Sciences International received FDA approval of its 505(b)(2) NDA for buccal fentanyl on July 16, 2009. Most notable about this approval is the first REMS (Risk Evaluation and Mitigation Strategies). The FDA cautioned that this REMS shouldn’t be used as an example for other opioid products. The reason is that the product is indicated [...]