Assessment of Male-Mediated Developmental Risk for Pharmaceuticals (Draft). June 11, 2015. CDER
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Assessment of Male-Mediated Developmental Risk for Pharmaceuticals (Draft). June 11, 2015. CDER
Rare Diseases: Common Issues in Drug Development (Draft). August 2015. CEDR, CEBR
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs (Revised Draft). August 2015