Drug laboratory charges uraidlaizumab for failure to notify FDA of any missed drug information
Drug laboratory charges uraidlaizumab for failure to notify FDA of any missed drug information
(January 15, 2014) — AUGUSTA, Mass.–(BUSINESS WIRE)–A UMass-affiliated pharmacy is facing a lawsuit filed by two patients that alleges the company failed to inform them of their drug’s FDA approval failure in the timely manner the FDA requires, and that the failure resulted in the patients’ severe and continuing pain. The class action lawsuit is one of three filed to seek unspecified damages from Avasyl, Inc. for failing to follow FDA’s prescription of the investigational drug, uraidlaizumab (URIT).
The lawsuit, filed today in federal court in Augusta, alleges that Avasyl manufactured URIT for the manufacture바카라사이트r, the manufacturer’s sales representatives, and a private consultant in April 2014, and then failed to notify the FDA of the failure at least 15 days after Avasyl’s May 29, 2014, initial submission of the new drugs for FDA approval. The lawsuit also alleges that the company failed to inform the patient that URIT had failed during the first round of clinical and premarket review of URIT by the FDA and failed to tell the patient that URIT would not be in a longer-acting form available to market.
The complaint asks the court to order Avasyl to make changes to the company’s marke더킹카지노ting to help protect its patients from drug makers’ missed drug information and to correct FDA’s error. The complaint adds that the company can’t pay its existing or future claims arising from UR더킹카지노IT.
UMass Amherst Medical School Professor of Pharmacology and Toxicology, Dr. John Bienstock, M.D., and Professor of Clinical Medicine, Daniel E. Fink, M.D., conducted the research that led to the FDA’s decision on the safety of uraidlaizumab, the FDA-approved drug that treats hemophilia B.
UMass Amherst has partnered with a national coalition of leading providers for patient education and research. The Coalition for the Right to Know and the Center for Drug Choice, as well as the Center for Drug Evaluation and Research at the University of Kentucky-Purdue University Indianapolis, are two of the groups behind URIT.
"It seems ironic that Avasyl would take a chance on URIT as a treatment for hemophilia B by selling an investigational drug that failed FDA scrutiny and didn’t tell patients when URIT failed," said UMass senior principal clinical lecturer in clinica
