US & FDA Developments

  • The Center for Devices and Radiological Health (CDRH) has moved! to the FDA White Oak Campus in Silver Spring, Maryland (located at 10903 New Hampshire Avenue, Silver Spring, MD 20993). Updates are available at: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ucm142391.htm.
  • On 3 August 2009, FDA announced the rates for prescription drug user fees for fiscal year (FY) 2010 (see: http://edocket.access.gpo.gov/2009/pdf/E9-18457.pdf) . The notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720). These fees are effective on 1 October 2009, and will remain in effect through September 30, 2010. For applications and supplements that are submitted on or after October 1, 2009, the new fee schedule must be used. Invoices for establishment and product fees for FY 2010 will be issued in August 2009, using the new fee schedule.
  • On 3 August 2009, FDA announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010 (see: http://edocket.access.gpo.gov/2009/pdf/E9-18456.pdf) . The fees apply from October 1, 2009, through September 30, 2010. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. The document provides information on how the fees for FY 2010 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
  • FDA has created a website: Reporting Drug Quality Problems for consumers and healthcare professionals, available at: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm172498.htm a flyer is also available at: http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/UCM173143.pdf.
  • On 8 July, FDA launched a new website, containing facts and myths about generic drugs. The agency noted that seven out of 10 prescriptions filled in the US are for generics. The new site is available here.
  • On 22 June , President Obama signed H.R. 1256, the Family Smoking Prevention and Tobacco Control Act (the Act), into law. The Act grants FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. The Act authorizes FDA to require disclosure of tobacco product ingredients and additives; regulate ‘‘modified risk’’ tobacco products; create standards for tobacco products, including standards for the reduction or elimination of certain constituents; restrict sales, distribution, advertising, and promotion of tobacco products; and require stronger health warnings on packaging. The Act also requires FDA to issue its 1996 final regulation restricting the sale and distribution of nicotine-containing cigarettes and smokeless tobacco products. The rule contains provisions designed to limit young people’s access to tobacco products, as well as restrictions on marketing to curb the appeal of these products to minors. A copy of the Act is available at http://www.fda.gov/tobacco.
    • FDA is establishing a public docket to obtain information on the implementation of the Act, in order to provide an opportunity for all interested parties to provide information and share views on the implementation of the new law. Submit comments to Docket FDA-2009-N- 0294 by 29 September 2009

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