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A Regulatory Affairs Professionals Society enforcement session discusses FDA drug inspections that appear to be paying closer atte...[ Price : $8.95]
FDA approves a Risk Evaluation and Mitigation Strategies for Cephalon's Nuvigil (armodafinil) tablets and Provigil (modafinil) tab...[ Price : $8.95]
A new FDA guidance describes the qualification process for drug development tools, such as biomarkers and patient-reported outcome...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on the qualification process for drug development tools.[ Price : $8.95]
FDA warns consumers that Hyland Teething Tablets may contain inconsistent amounts of belladonna, which can cause serious harm at l...[ Price : $8.95]
CBERs Laboratory Quality System program gains national accreditation for13 testing methods recognized under the ISO/IEC 17025 stan...[ Price : $8.95]
FDA approves a Warner Chilcott NDA for Lo Loestrin FE (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tabl...[ Price : $8.95]
A citizen petition asks FDA to designate FazaClo 200 mg as the reference-listed drug for clozapine orally disintegrating tablets.