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FDA says it has added a Warning to labeling for Astellas Veozah about the risk of rare but serious liver injury.[ Price : $8.95]
A new National Academies book on collaboration in rare disease drug development lists steps it recommends that FDA take.[ Price : $8.95]
FDA publishes a guidance on submitting ANDA amendments under GDUFA 3.[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for Cyclomedica Australias Technegas (technetium Tc 99m-label...[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for Marinus Pharmaceuticals Ztalmy (ganaxolone), indicated fo...[ Price : $8.95]
CDERs Office of Prescription Drug Promotion cites AbbVie in a just-released untitled letter over its television direct-to-consumer...[ Price : $8.95]
FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.[ Price : $8.95]
FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.