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The U.S. Court of Appeals for the District of Columbia has rejected petitions from a cohort of drug and devicemakers that seek to overrule a decision last year allowing to proceed a lawsuit accusing the companies of indirectly funding terrorist acts in Iraq. Read More
A federal court has rejected a lawsuit from the Pharmaceutical Research and Manufacturers of America (PhRMA) filed against HHS that would seek to block states from importing prescription drugs from Canada. Read More
In his State of the Union address on Tuesday night, President Biden continued pressing for a $35-per-month limit on insulin for diabetics of all ages. Read More
Drugmakers have a long way to go when it comes to fulfilling their required postmarket reporting, according to the FDA’s most recent numbers. Read More
Sage Therapeutics and Biogen announced Monday that the FDA has given priority review to the companies’ new drug application (NDA) for zuranolone for the treatment of major depressive disorder (MDD) and postpartum depression (PPD). Read More
The FDA has warned consumers not to use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination that has caused permanent vision loss from eye infections and one death. Read More
As the Biden administration prepares to end the COVID-19 public health emergency on May 11, the FDA must decide what to do with dozens of temporary guidances issued during the public health emergency. Read More
Becoming — and remaining — in compliance with FDA regulations is often a result of creating and maintaining a quality culture but measuring the maturity of that culture takes more than just looking at metrics, according to several experts speaking at a recent FDAnews webinar. Read More