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Federal Register Notice: FDA releases a guidance: Investigational New Drug Applications (INDs) Determining Whether Human Research...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Bio Focus, Dako Denmark, Deroyal Cientifica De Latinoamerica, Graftys, Irenda, S...[ Price : $8.95]
FDA adds questions and answers to its guidance on GDUFA implementation.[ Price : $8.95]
A Tufts Center for the Study of Drug Development Impact Report says causes of drug failures in clinical trial vary according to tr...[ Price : $8.95]
FDA rejects several requests from Physicians for Responsible Opioid Prescribing for changes to opioid labeling.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on the value of CDRHs application form for participation in the Medical Device Fellows...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: entitled Bioequivalence Recommendations for Fluticasone Propionate; Salmet...[ Price : $8.95]
A food and drug lawyer says NDA sponsors who use contract manufacturing organizations should define change control in their qualit...