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FDA approves Mylans ANDA for a generic form of Janssens Risperdal.[ Price : $8.95]
FDA announces August labeling changes to 41 drugs, including boxed warnings for 12 antipsychotics.[ Price : $8.95]
CDER deputy director Douglas Throckmorton tells a regulatory affairs meeting that new policies under the Centers Good Review Manag...[ Price : $8.95]
An appeals court panel says Teva is not entitled to marketing exclusivity for generic Risperdal in a patent-listing dispute.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Concept Labs, Forest Labs, Drs. Foster and Smith, Hamilton Medical Center, Ovati...[ Price : $8.95]
FDA Center directors, participating in a roundtable discussion of the agencys Critical Path Initiative, provide anecdotal impressi...[ Price : $8.95]
CBER senior program management officer Vada Perkins discusses mandatory electronic labeling submissions that become effective 10/1...[ Price : $8.95]
FDA gives Cephalon a complete response letter to its sNDA for an expanded Fentora indication for non-cancer breakthrough pain.