Regulatory Roundup: Week of July 30, 2012

Article

FDA announces FY 2013 user fee rates and EMA furthers relationship with Japan.

FDA has announced rates for prescription drug user fees for fiscal year (FY) 2013, as authorized by the Prescription Drug User Fee Amendments (PDUFA V) signed into law on July 9, 2012. FDA is required to set fee revenue amounts for applications, establishments, and products each year. The FY 2013 rates, effective Oct. 1, 2012 through Sept. 30, 2013 as listed in the Federal Register, are: application fees for an application requiring clinical data, $1,958,800; an application not requiring clinical data or a supplement requiring clinical data, $979,400; establishment fees, $526,500; and product fees, $98,380. The new fee schedule applies to applications and supplements submitted on or after Oct. 1, 2012.

Cooperation and interaction between Japanese and European pharmaceutical regulators has improved since 2009, according to a report released by the European Medicines Agency (EMA). EMA reports an increase in the exchange of information and interaction between the two regions, including a new Japanese liaison officer and increased conference attendance. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the new Japan and EMA cooperation.

Recent Videos
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Simon Wright from Almac Pharma Services chats about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.
Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.
Miguel Forte from ISCT and Kiji Therapeutics talks about the potential impact of a changing European political landscape.
Miguel Forte from ISCT and Kiji Therapeutics provides his insights into the changing political landscape in the US as well as legislative and regulatory adjustments
Miguel Forte from ISCT and Kiji Therapeutics chats about expectations for 2025 and the future technology agenda for industry.
Sheryl Johnson from Orbia Fluor & Energy Materials chats about gender diversity, how women are helping to advance innovation, sustainability challenges, and progress in the field of inhaled drugs.
Mike Baird from Schlafender Hase gives his predictions for how AI and ML may find use in the industry moving forwards and provides some predictions about M&A and the changing US government administration.