Examples of Phase IV Study in a sentence
See, e.g., Charles Steenburg, The Food and Drug Administration’s Use of Postmarketing (Phase IV) Study Requirements: Exception to the Rule?, 61 FOOD & DRUG L.J. 295, 323 (2006) (Subpart H “extend[s] only to drugs and biological products that target[] ‘serious or life-threatening illnesses’ and offer[] a ‘meaningful’ benefit over existing treatments”).
Protocol No. 704.351 Evaluation of Synergy between Natrecor and Furosemide on Renal and Neurohormone Responses in Chronic Heart Failure: A Phase IV Study, Scios Inc., 2003-2005 (multicenter, U.S., randomized cross-over trial).
Karnofsky Performance Status as A Predictive Factor for Cancer-Related Fatigue Treatment with Astragalus Polysaccharides (PG2) Injection-A Double Blind, Multi-Center, Randomized Phase IV Study.
Heather and the rest of participants of the Phase IV Study it would not have been possible to achieve the widespread dissemination of SBI in our country.
ACTD Parts I & II (only), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR), and Phase IV Study results/ report* (if applicable).*Only applicable to MR products that were issued before FDA Circular No. 2013-004.