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Federal Register notice: FDA makes available a final guidance entitled ANDA Submissions Content and Format.[ Price : $8.95]
Two stakeholders provide comments on an FDA public hearing on biologic product marketplace competition.[ Price : $8.95]
Six drug companies give FDA comments and recommendations on a draft guidance on using liquids and/or soft foods as drug administra...[ Price : $8.95]
A study of pediatric exclusivity trials finds that they have yielded useful information, but at a very high cost to consumers.[ Price : $8.95]
FDA clears an OrthoXel 510(k) for the Apex Tibial Nailing System, a fracture fixation device that can be surgically implanted from...[ Price : $8.95]
HHS cancels an FDA fetal tissue contract with Advanced Biosciences Research and opens an investigation into all fetal tissue resea...[ Price : $8.95]
FDA clears a Synergy Biomedical 510(k) for the Biosphere Flex, a strip-format bone graft product made of porous, bioactive glass.[ Price : $8.95]
Researchers say pivotal clinical trials often are not the main reason for the high cost of drug development.