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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
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
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
The FDA’s proposed transformation of the Office of Regulatory Affairs (ORA) will not only see the office transfer all compliance functions to product centers but could also lead to more efficient inspection planning and execution as well as more effective and timelier regulatory compliance actions. Read More
The letter referenced the FDA’s list of 128 drugs currently in shortage, including commonly used medications that treat cancer, heart failure, infections and respiratory illnesses. Read More