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Over the past week, the FDA has issued draft guidances on inborn errors of metabolism, clinical trial postmarketing studies and human cellular and gene therapy products. Read More
It is not clear yet whether the reported cases are linked to the drugs, to the patients’ underlying conditions or other factors, the EMA stated. Read More
In an effort to improve adherence with postmarketing requirements (PMR), the FDA has laid out the circumstances under which noncompliance with PMRs is justified in a new draft guidance. Read More
Acknowledging the complexity of human cellular and gene therapy (CGT) products, the FDA has written a draft guidance intended to help manufacturers manage and report changes in products, based on a lifecycle approach, and how to assess the effect of manufacturing changes on product quality. Read More
Merck has asked a federal judge to issue an order granting a summary judgment in its case against HHS over the Inflation Reduction Act (IRA) on the grounds that “no genuine issue as to any material fact exists.” Read More
A revised report from the Institute for Clinical Evaluation and Research (ICER) has reiterated that two experimental gene therapies for sickle cell disease (SCD) would likely be cost-effective if priced at $2 million. Read More
The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Read More
The European Medicines Agency (EMA) is conducting a safety review of GLP-1 receptor agonists such as Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) following 150 reports from the Icelandic Medicines Agency of suicidal thoughts and self-injury in people using one of the drugs for weight loss or type 2 diabetes. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as the WCG MAGI Clinical Research Conference and a webinar from FDAnews, a WCG company on design control. Read More
The CMS notice comes after U.S. Supreme Court decision that ruled the agency had underpaid for 340B medications from 2018 through most of 2022. Read More