Regulatory Roundup: PDUFA Fees Published, And More.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Regulatory Roundup: PDUFA Fees Published, And More.

The US Food and Drug Administration announced last week that it mailed invoices for product and establishment fees as part of the Prescription Drug User Fee Act (PDUFA). Payments are due Oct. 1, 2010. PDUFA, originally enacted in 1992, authorizes FDA to collect fees from companies that produce certain human drug and biological products. User fees help to expedite the drug approval process. The rates for fiscal year 2011 are posted here.

According to new data released by the US Centers for Disease Control and Prevention (CDC), vaccinations among teenagers (ages 13 to 17) are on the rise. Coverage for this age group increased 15% according to the 2009 National Immunization Survey-Teen (NIS-Teen) results, which included more than 20,000 teens and was conducted by CDC. Among vaccines on the rise are: tetanus-diphtheria-acellular pertussis, meningococcal conjugate, and human papillomavirus (one dose as compared to three doses). "This year's data are mixed," said Anne Schuchat, MD, director of CDC's National Center for Immunization and Respiratory Diseases in the press release about the study. "We can see that more parents of adolescents are electing to protect their children from serious diseases such as pertussis, meningitis, and cervical cancer, but there is clear room for improvement in our system's ability to reach this age group."