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Federal Register Notice: FDA submits a collection of information on a draft guidance on a risk-based approach to the oversight of ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance on stability testing of drug substances and products for ANDAs.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on pre-storage leukocyte reduction of whole blood and blood components intended f...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Aino Co., Ltd. of North China Pharmaceutical Group, Arriol International, Atlant...[ Price : $8.95]
The Economic Times reports that Ranbaxy missed its intended 9/21 launch of a generic form of Novartis Diovan.[ Price : $8.95]
CDER Office of Manufacturing and Product Quality director Steven Lynn reviews drug sponsor responsibilities when using outsourced ...[ Price : $8.95]
A CDER official unveils the agencys plans for a new automated field alert report system for drug manufacturers to use when reporti...[ Price : $8.95]
A year after the event, FDA now says a Custom Medical Specialties recall of 14 types of surgical kits was Class 1.