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The FDA’s Center for Biologics Evaluation and Research (CBER) said it plans to resume normal operations starting calendar year 2023 following the more than two-year focus on COVID-19, which seriously impacted the center’s operations. Read More
Forty-nine states that are suing more than 20 generic drugmakers over alleged price-fixing can’t force the companies to hand over the profits of their alleged scheme as punishment, a federal judge has determined. Read More
An FDA advisory committee voted unanimously, 13 to 0, on Friday to recommend Bluebird Bio’s investigational gene therapy betibeglogene autotemcel (beti-cel) for patients with beta-thalassemia who require regular red blood cell transfusions. Read More
As Congress continues to search for ways to rein in prescription drug costs, a new study published in JAMA this week showed that the price of new medicines has spiked from a median price of $2,115 per year in 2008 to $180,007 per year in 2021. Read More
With 392 ayes and 28 nays, the U.S. House of Representatives passed a package of legislation late Wednesday to reauthorize the FDA’s prescription drug, generic drug, biosimilar and medical device user fee programs. Read More
In a new procedural document released on Wednesday, the FDA directs its Office of Generic Drugs (OGD) to request additional data from sponsors of generic combination products if the generic product’s user interface is substantially different from the original product. Read More
Nephron Pharmaceuticals’ recall of approximately 2 million doses of 20 drug products last week followed a March 28 to April 20 inspection of the company’s outsourcing facility in West Columbia, S.C., that unveiled numerous quality lapses. Read More