U.S. Food and Drug Administration Archives

Tag: U.S. Food and Drug Administration

Over Half of People with Lupus Would Take COVID-19 Vaccine, Shows LRA Survey

Updated January 4, 2021 New York, NY– December 16, 2020. More than half of people with lupus (54%) are willing to take a COVID-19 vaccine if it is free and determined safe by scientists according to results of a survey conducted by the Lupus Research Alliance (LRA). However, it is important to note that 24% […] Read More

COVID-19 Caused Hydroxychloroquine Issues for Third of Lupus Patients, New LRA Survey Finds

NEW YORK, NY, May 28, 2020. More than one third of people with lupus experienced significant issues filling their hydroxychloroquine (Plaquenil) prescriptions during the COVID-19 pandemic, according to results of a new survey conducted by the Lupus Research Alliance (LRA). Hydroxychloroquine shortages in March and April coincided with early data broadly reported in the media […] Read More

Lupus Research Alliance Congratulates Dr. Robert Califf on FDA Commissioner Appointment

February 17, 2022 The Lupus Research Alliance applauds the appointment of Dr. Robert Califf as the Commissioner of the U.S. Food and Drug Administration (FDA). We are confident that Dr. Califf’s world-class expertise in healthcare quality and outcomes as well as clinical research will well enable him to guide the FDA in fulfilling its mission, […] Read More

2021 Senate Budget Bill Includes Increases for Medical Research

November 11, 2020 The Lupus Research Alliance is pleased to share details of the 2021 spending package announced by the U.S. Senate last night with several potential “wins” for lupus research. While not 100% in line with our requests, funding for lupus research is substantial and due in large part to the hard work of […] Read More

LRA Writes President Supporting Dr. Janet Woodcock for FDA Commissioner

March 31, 2021 As part of the LRA’s mission to accelerate development and availability of much-needed new diagnostics and treatments for lupus, the organization’s President and CEO, Mr. Kenneth M. Farber, submitted a letter to President Joseph Biden to express LRA’s strong support for Dr. Janet Woodcock to be nominated for Commissioner of the U.S. […] Read More

Three Healthcare Organizations Issue Statement on FDA Action to End Emergency Authorization of Medications to Treat COVID-19

June 24, 2020 Joint Statement of the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists on new FDA action to Remove Emergency Use Authorization of Medications to Treat COVID-19 The American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists issued a statement “emphasizing that the FDA’s recent announcement to cancel the emergency […] Read More

Aurinia Completes NDA and Requests Priority Review of Voclosoporin by FDA for Lupus Nephritis

May 28, 2020 The Lupus Research Alliance is pleased to share that Aurinia Pharmaceuticals Inc submitted a New Drug Application (NDA) to the U.S. FDA for voclosporin as a potential treatment for lupus nephritis with request for a priority review. Lupus nephritis is one of the most common complications of systemic lupus erythematosus, a serious […] Read More

MARCH 26 STATEMENT: Lupus Research Alliance Puts Plaquenil (Hydroxychloroquine) Shortage into Perspective for Lupus Community

March 26, 2020 The Lupus Research Alliance (LRA), the world’s leading research organization dedicated to lupus research, continues to watch rapidly changing developments regarding COVID-19 and is closely monitoring the policies and actions of the federal government, healthcare agencies, medical organizations and the pharmaceutical industry on behalf of people with lupus. Thrust into the spotlight […] Read More