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FDA releases a guidance on the Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products Cont...[ Price : $8.95]
FDA grants Biostage an orphan drug designation for Cellspan Esophageal Implant to restore the structure and function of the esopha...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for Pfizers meningitis B vaccine Trumenba for patent term ext...[ Price : $8.95]
FDA clears a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment.[ Price : $8.95]
Federal Register Notice: FDA posts a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content.[ Price : $8.95]
FDA releases a draft guidance on Physiologically Based Pharmacokinetic Analyses Format and Content that outlines the recommended ...[ Price : $8.95]
FDA grants Arsanis fast track status for ASN100 for preventing Staphylococcus aureus pneumonia in mechanically ventilated patients...[ Price : $8.95]
FDA commissioner Robert Califf says that approval of stem-cell therapies should be based on scientific evidence.