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Attorney Brian Coggio describes the impact of an inter partes review on an FDA 30-month stay of a generic drug ANDA during patent ...[ Price : $8.95]
FDA looks for nominations for participants in a voluntary Medical Device Development Tools pilot program intended to improve the d...[ Price : $8.95]
FDA says consumers should be aware that despite Internet claims to the contrary, there are no approved vaccines or drugs for Ebola...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Clinical Pharmacology Labeling for Human Prescription Drug and Biological ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance for medical devices: De Novo Classification Process (Evaluation of Automati...[ Price : $8.95]
Federal Register Notice: FDA reopens the comment period for a draft guidance on best practices in developing proprietary names for...[ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 9/5 on the clinical development of drugs for preventing serious infections ca...[ Price : $8.95]
Federal Register Notice: FDA corrects a 6/10 final rule on postmarketing safety reports for human drug and biological products.