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FDA issues a draft guidance recommending to applicants and manufacturers drug shortage information to be communicated to FDA to as...[ Price : $8.95]
The political newsletter Roll Call says efforts to reauthorize a pandemic preparedness bill are likely to include a debate over gr...[ Price : $8.95]
FDA releases the form FDA-483 with three observations issued following an inspection at the Sugar Land, TX-based QuVa Pharma outso...[ Price : $8.95]
CDER director Patrizia Cavazzoni tells the Alliance for a Stronger FDA that the Center is in growth mode after the user fee reauth...[ Price : $8.95]
FDA approves a Synapse Biomedical PMA for the NeuRx Diaphragm Pacing System for use in patients with spinal cord injuries who rely...[ Price : $8.95]
FDA outlines research into potential pharmacodynamic biomarkers for biosimilar development.[ Price : $8.95]
Federal Register notice: FDA establishes a docket to obtain information and comments to help assess whether in-home disposal produ...[ Price : $8.95]
CBER director Peter Marks says Covid-19 vaccine makers will be given advice in June on the next booster vaccine composition for fa...