ALBUMIN HUMAN | N020899 | GE HEALTHCARE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from International Contrast Ultrasound Society FDA-2018-P-3354 The International Contrast Ultrasound Society filed this citizen petition under sections 502 and 505 of the Federal Food, Drug & Cosmetic Act requesting that the FDA Commissioner remove the boxed warnings from the labels of three FDA-approved ultrasound contrast agents—Optison, Definity, and Lumason | Other | 2020-09-17 | Denied | International Contrast Ultrasound Society |
Citizen Petition from International Contrast Ultrasound Society FDA-2018-P-3354 The International Contrast Ultrasound Society filed this citizen petition on August 29, 2018, requesting that the FDA remove the boxed warnings from the labels of ultrasound contrast agents (UCAs) Optison, Definity, and Lumason, arguing that peer-reviewed scientific data accumulated since 2007 demon | Other | 2018-09-05 | Denied | International Contrast Ultrasound Society |
International Contrast Ultrasound Society (ICUS) Steven Feinstein, et al - Ci... FDA-2011-P-0725 The International Contrast Ultrasound Society, represented by Steven Feinstein and others, filed this citizen petition under 21 C.F.R. §§ 10.30 and 201.57(c)(1) requesting that the FDA Commissioner remove boxed warnings from ultrasound contrast agents Definity and Optison, arguing that current scien | Other | 2011-10-11 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| NPP | May 9, 2028 | Active |