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In its latest batch of Warning Letters, FDA cites Bioenergy, Claris Lifesciences, CP Pharmaceuticals, and Ipsen Group-Tercica.[ Price : $8.95]
Federal Register Notice: FDA plans a public meeting 2/9/10 on incorporating new science into regulatory decisionmaking within CDRH...[ Price : $8.95]
ISTA Pharmaceuticals submits a supplemental NDA for once-daily bromfenac ophthalmic solution as a treatment for ocular inflammatio...[ Price : $8.95]
FDA approves Boehringer Ingelheim Pharmaceuticals Spiriva HandiHaler (tiotropium bromide inhalation powder) for reducing exacerbat...[ Price : $8.95]
Attorney Arnold Friede says that drug companies need to be aware of the rules that CDERs DDMAC applies when evaluating presentatio...[ Price : $8.95]
Roche decides to discontinue production of Zenapax (daclizumab) sterile concentrate for injection, indicated for prophylaxis of a...[ Price : $8.95]
Attorney Kurt Karst says that FDA and federal courts are concerned that companies filing ANDAs many years before they expect to be...[ Price : $8.95]
Public Citizen says that some Roche claims for Tamiflu havent been proven and healthy adults should not use the drug for routine f...