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As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and regulations that could impact your business. Read More
In this edition of Quick Notes we tackle regulatory activity across the pond in Britain and the EU with stories on increased EMA fees, electronic product information for medicines, an updated service to help pharmaceutical companies and repurposing of a drug to help prevent breast cancer. Read More
The COVID-19 public health emergency may be officially over, but the temporary changes it provoked in regulatory assessments are here to stay, experts said during the 18th Annual FDA Inspections Summit last week. Read More
Quality agreements between companies and third-party vendors should explicitly define key manufacturing roles and responsibilities and establish expectations for communication, such as by providing key contacts for both entities, says a regulatory expert. Read More
Public health officials, patient advocacy groups and health scholars have filed amicus briefs supporting the U.S. government as it fights a lawsuit from AstraZeneca claiming the Inflation Reduction Act’s (IRA)drug pricing negotiation provisions are unconstitutional. Read More
Over the past week, the FDA issued final guidance on real-time oncology review and cosmetic product facility registration and product listing. Read More
Untitled letters sent to Otsuka Pharmaceutical and Evofem Biosciences alleging false or misleading claims that inflated the effectiveness of the products in direct-to-consumer (DTC) advertising were recently released by the FDA Office of Prescription Drug Promotion (OPDP). Read More
After committing in March to cut 65 percent off the price of its long-lasting insulin Levemir (insulin detemir), Novo Nordisk has announced that it will discontinue its marketing of the product in the U.S. with supply disruptions beginning as early as January. Read More
The Senate Finance Committee voted 26-0 in favor of the Better Mental Health Care, Lower Drug Cost and Extenders Act which addresses pharmacy benefit manager (PBM) practices that sponsors Sen. Ron Wyden (D.-Ore.) and Sen. Mike Crapo (R.- Idaho) say drive up the cost of drugs. Read More