We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA encourages sponsors of new drug and biological products to take steps to reduce uncertainties that can affect the agency’s benefit-risk assessments, in a new guidance released yesterday. Read More
Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA this week issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
The House Judiciary Committee voted yesterday to advance a bill meant to stop drugmakers from engaging in anticompetitive practices, one day after marking up three separate bills that also target prescription drug prices. Read More
Both chambers of Congress voted yesterday to approve a stopgap measure funding the federal government, including the FDA, through Dec. 3, narrowly avoiding a government shutdown at midnight. Read More
Sponsors that plan to seek approval based on a single trial and confirmatory data should discuss their development program with the FDA, the agency said. Read More
The Senate is racing to vote on a stopgap measure keeping federal agencies, including the FDA, funded through Dec. 3, a critical step in avoiding a shutdown set to occur Friday. Read More
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), said his center continues to experience large losses of staff during the pandemic — possibly limiting CBER’s ability to achieve its goals for next year. Read More
AstraZeneca’s rare-diseases subsidiary Alexion has announced that it will acquire Caelum Biosciences, which nets the company a potentially first-in-class monoclonal antibody for the treatment of the rare disease light-chain (AL) amyloidosis. Read More
As part of its forward-looking initiative to drive greater use of real-world evidence (RWE), the FDA has issued detailed guidance for sponsors and researchers who intend to use electronic health records (EHRs) and medical claims to support drug approvals and post-approval requirements. Read More
The Cherokee Nation territory in Oklahoma has reached a settlement of $75 million with the three largest drug wholesalers in the U.S. over their alleged role in the opioid epidemic. This is the first settlement with a tribal government in the opioid litigation. Read More