Repurposing, repositioning - by whatever name, the 505(b)(2) drug development pathway is gaining traction. I will be giving a talk entitled “505(b)(2) Product Candidate Selection-Which Old Dog to Rejuvenate” on December 10 at the Drug Repurposing Strategies meeting. The conference costs $1695 but friends of Camargo can get a $400 discount - just contact me [...]
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You are currently browsing the Drug Kennel weblog archives for the month November, 2008.
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Latest
- 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
Medicaid paid for unapproved DESI drugs
Published November 25th, 2008 in News Commentary. 0 CommentsA minor ripple in the media, the Associated Press reviewed Medicaid records and found that since 2004, Medicaid has paid at least $200 million for unapproved drugs (perhaps $50MM per year). “Unapproved” sounds scary, right? These drugs are DESI drugs that are not normally reimbursed. $200 million pales in comparison to the amounts that Medicaid has paid. For [...]