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Public Citizen health gadfly Sidney Wolfe says a draft FDA guidance on communicating drug risk information tilts too far toward in...[ Price : $8.95]
CDER outlines five generic drug regulatory science priorities that will help generic drugs get to market faster.[ Price : $8.95]
FDA asks Acura Pharmaceuticals for an additional nasal abuse liability study on its Aversion hydrocodone with acetaminophen tablet...[ Price : $8.95]
Federal Register Notice: FDA determines that several drug products were not withdrawn from sale for reasons of safety or effective...[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Immunogenicity Assessment for Therapeutic Protein Products.[ Price : $8.95]
Amgen recalls nine lots of Aranesp (darbepoetin alfa) 500 mcg prefilled syringes from non-U.S. distributors, wholesalers and a num...[ Price : $8.95]
FDAs Pulmonary-Allergy Drugs Advisory Committee votes to recommend that existing data support approval of Boehringer Ingelheims Sp...[ Price : $8.95]
PhRMA asks FDA to eliminate its proposed hierarchical framework for degrees of similarity in using clinical pharmacology data to d...