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The Supreme Court voted 6-3 on Monday to lay out a new standard that makes it easier for companies and other entities to challenge federal rules, potentially allowing new challenges to regulations that have been in place for decades. Read More
Three former executives of Chicago-based tech startup Outcome Health have been sentenced for their roles in a six-year scheme involving approximately $1 billion in fraudulently obtained funds gained from a pharmaceutical advertising scheme. Read More
Hoau-Yan Wang, a former paid consultant at Cassava Science and professor at the City University of New York (CUNY), is now the subject of a federal indictment charging that he milked the NIH for $16 million in grant money based on falsified data. Read More
The Supreme Court’s reversal of a 40-year-old precedent that had smoothed the regulatory agency pathway now makes it easier for courts to step in with their own interpretation of a law’s effect on regulatory issues. Read More
The FDA has published overdue draft guidance on developing diversity action plans for clinical trials, moving the agency a step closer to the statutory mandate that all phase 3 trials include such plans. Read More
The EU’s Committee for Medicinal Products for Human Use (CHMP) isn’t supporting two drugs intended to treat patients with amyotrophic lateral sclerosis (ALS) and Duchenne muscular — diseases that have also struggled to get approved treatments in the US. Read More
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Dec. 31, 2023 to keep you updated on laws and regulations that could impact your business. Read More
The FDA has approved Verona Pharma’s Ohtuvayre (ensifentrine), the first inhaled maintenance chronic obstructive pulmonary disease (COPD) drug in more than two decades, and granted marketing authorization of a novel in-office hepatitis C virus (HCV) test that will allow clinicians to receive rapid results and address the issue in one visit. Read More
Assuring the consistent performance of a drug-delivery combination product through the outputs that measure that performance is the focus of an FDA draft guidance released July 1. Read More
This week, the FDA published a final guidance for small businesses on LDTs. The long-awaited draft guidance on diversity in clinical trials was also published. The agency modified its list of recognized standards and is seeking comments on its IT and customer experience strategies. Read More