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Online Warning Letter Links Available

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CDER publishes links to Warning Letters and notices of violation from DDMAC and FDA headquarters.

FDA Fast Track for Heart Failure Drug

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FDA grants fast track status to ARCA biopharma for Gencaro (bucindolol HCl), an investigational beta-blocker and mild vasodilator.

FDA Again Rejects Old Antibiotic 30-month Stay

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Attorney Kurt Karst says that FDA appears to have definitively resolved questions about a 30-month stay for so-called old antibiot...

No Change in FDAs Pro-industry Bias, Amalgam Lawyer Says

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In a Charleston Gazette (WV) op-ed, anti-mercury lawyer Charles G. Brown says the Obama administrations failure to change FDAs pro...

FDA Reviewing Meridia Cardiac Event Data

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FDA says it is reviewing preliminary SCOUT study results suggesting that Abbotts Meridia is associated with an increased cardiovas...

FDA OKs Abilify for Autism Episodes

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FDA approves a Bristol-Myers Squibb and Otsuka Pharmaceutical Co. sNDA for Abilify (aripiprazole) for treating irritability associ...

Animal Drug Sponsor Changed to Huvepharma

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Federal Register Final rule: FDA amends the animal drug regulations to change the sponsor to Huvepharma for 10 NADAs.

FDA OKs Pharmacia & Upjohn sNADA for Heifers

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Federal Register Final rule: FDA approves a Pharmacia & Upjohn supplemental NADA for medicated feeds containing melengestrol aceta...

Albanese Debarred

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Federal Register Notice: FDA issues an order debarring Anthony Albanese from providing services to any person with an approved or ...

Glaxo Pulls sNDA on Avodart

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GlaxoSmithKline withdraws a supplemental NDA for Avodart (dutasteride) for prostate cancer risk reduction among men at increased r...