Integrated Summary of Effectiveness. Final. October 7, 2015. CDER
FDA Guidance. Brief Summary and Adequate Directions for Use
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs. August 5, 2015. Draft, Revision II. Advertising.
FDA Guidance. Considerations for the Design of Early-Phase Trials of …
Considerations for the Design of Early-Phase Trials of Cellular and Gene Therapy Products; Guidance for Industry. Final. June 9, 2015. CBER
FDA Guidance. Assessment of Male-Mediated Developmental Risk for Pharmaceuticals
Assessment of Male-Mediated Developmental Risk for Pharmaceuticals (Draft). June 11, 2015. CDER
FDA Guidance. Rare Diseases: Common Issues
Rare Diseases: Common Issues in Drug Development (Draft). August 2015. CEDR, CEBR
FDA Guidance. Brief Summary and Adequate Directions for Use
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
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