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PhRMA says a Massachusetts federal court should certify for appeal its flip-flop decision that ultimately ruled that CCS Medical S...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Ajes Pharmaceuticals, Cheng Fong Chemical Co., and Elite Laboratories.[ Price : $8.95]
Attorney Sandra Edelman describes the legal distinction applied by the 2nd Circuit Appeals Court in determining whether an adverti...[ Price : $8.95]
FDA warns Chinas Cheng Fong Chemical CGMP violations in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDAs New Jersey District Office warns Elite Laboratories about its failure to implement Postmarketing Adverse Drug Experience repo...[ Price : $8.95]
FDA and the European Medicines Agency agree on operating procedures for a new joint cluster on rare diseases.[ Price : $8.95]
Federal Register Notice: FDA corrects a 9/19 notice entitled "A List of Biomarkers Used as Outcomes in Development of FDA-Approved...[ Price : $8.95]
Janssen Research & Development files a supplemental NDA for Imbruvica (ibrutinib) for treating patients with marginal zone lymphom...