FDA Launches Industry Basics Website - Pharmaceutical Technology

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FDA Launches Industry Basics Website


ePT--the Electronic Newsletter of Pharmaceutical Technology

As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products. The site addresses questions, such as, “How do I know if my product is regulated by FDA?” and “What should I expect during an inspection?”

The site also provides resources and contacts for drug manufacturers just getting into the business, or perhaps for those who manufacture outside the United States and want to sell their products in the US, and thus, be approved by the agency. For example, a list of frequently asked questions and educational resources is part of the site, as is a page that reviews the drug application and review process.

The site is separate from the FDA Basics webpage that the agency launched in January 2010. That site includes key questions and answers about the agency, including short videos that explain agency activities, and recorded conversations with officials about the work of their offices. The agency transparency initiative webpage notes that, as of Nov. 30, 2010, 957,008 visitors had viewed the FDA Basics site and left 8781 comments.

The new site includes a video message from Commissioner Margaret Hamburg about communication with the agency. The site is one of 19 action items called for in the agency’s report, “FDA Transparency Initiative: Improving Transparency to Regulated Industry.” Other action items still to be tackled include:

  • Setting an agencywide expectation that questions emailed to FDA involving the regulatory process will, whenever possible, receive an answer within five business days, or a response stating when an answer can be expected
  • Making agency presentations at key meetings widely available
  • Developing and executing a project to promote uniform processes and procedures across field districts.

Additional action items are listed here.

See related blog post, “FDA Bares All

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