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Federal Register notice: FDA posts a draft guidance entitled Considerations for the Use of Real-World Data and Real-World Evidence...[ Price : $8.95]
Federal Register notice: FDA publishes modifications to its list of standards FDA recognizes for use in premarket reviews: Modific...[ Price : $8.95]
FDA issues a draft guidance on using real-world data and evidence to support NDA and BLA decisions.[ Price : $8.95]
FDA publishes a guidance on the types of changes to an approved BLA to be documented in an annual report.[ Price : $8.95]
The Justice Department says Entellus Medical and the owner of a Georgia surgical practice will pay $4.2 million to resolve a whist...[ Price : $8.95]
A CDER Manual of Policies and Procedures outlines policies and responsibilities of meeting participants when they are working remo...[ Price : $8.95]
FDA lifts a clinical hold against an Aprea Therapeutics clinical trial evaluating the combination of its lead compound, eprenetapo...[ Price : $8.95]
FDA grants Pfizer and BioNTech an expanded emergency use authorization for their Covid-19 vaccine booster to include individuals 1...