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The U.S. Patent and Trademark Office (PTO) has found against Longhorn Vaccines & Diagnostics for committing “egregious abuse” of the Patent Trial and Appeal Board (PTAB) process during its review of Longhorn patent claims filed against Spectrum Solutions’ COVID-19 test. Read More
Integra LifeSciences has initiated a voluntary recall of all its products manufactured at its Boston facility for the past five years after discovering, through an internal investigation, that the products contained higher than acceptable levels of endotoxins. Read More
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as webinars and conferences on subjects ranging from advanced gene and cell therapy, ICH E8 R1 recommendations and FDA’s sterilization pilot. Read More
Republican lawmakers are renewing their push to speed FDA approvals by allowing the agency to automatically approve drugs and devices that have been approved and sold in other developed and trustworthy countries. Read More
The Ironworkers District Council of New England Health and Welfare Fund has filed a class action complaint against Teva Pharmaceuticals accusing the company of a nearly decade-long anticompetitive scheme to delay generic competition for its QVAR (beclomethasone dipropionate HFA) asthma inhalers. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The FDA slapped Centaur Pharmaceuticals with a 10-observation Form 483 after investigators observed destruction of good manufacturing practice (GMP) documents, among other serious lapses. Read More
The Federal Trade Commission (FTC) is ramping up its oversight of health data collected electronically and plans to issue a new rule on notifications of health breaches to clarify the existing rule’s applicability to health apps and other similar technologies. Read More