✦ LIBER ✦

Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective

✍ Scribed by Donald L. Patrick; Laurie B. Burke; John H. Powers; Jane A. Scott; Edwin P. Rock; Sahar Dawisha; Robert O'Neill; Dianne L. Kennedy

No coin nor oath required. For personal study only.

📜 SIMILAR VOLUMES

Guidance for industry: patient-reported

✍ U.S. Department of Health and Human Services FDA Center for Drug Evaluation and 📂 Article 📅 2006 🏛 BioMed Central 🌐 English ⚖ 583 KB

PCN160 PATIENT-REPORTED OUTCOMES SUPPORT

✍ Y Hao 📂 Article 📅 2010 🏛 John Wiley and Sons 🌐 English ⚖ 76 KB

PHP59 LABEL CLAIMS BASED ON PATIENT REPO

✍ J Scott 📂 Article 📅 2008 🏛 John Wiley and Sons 🌐 English ⚖ 75 KB

PCN57 PATIENT REPORTED OUTCOMES IN LABEL

✍ M Caron; MP Emery; P Marquis; E Piault 📂 Article 📅 2007 🏛 John Wiley and Sons 🌐 English ⚖ 67 KB

Patient-reported outcomes in fda-approve

✍ Palsgrove, A.C.; Vanya, M. 📂 Article 📅 2013 🏛 John Wiley and Sons 🌐 English ⚖ 70 KB

PMC55 IMPACT OF THE FDA DRAFT GUIDANCE O

✍ M Mordin; M Clark; C Siersma; K Copley-Merriman; A Gnanasakthy 📂 Article 📅 2009 🏛 John Wiley and Sons 🌐 English ⚖ 87 KB