Tuesday, January 11, 2011

FDA's New Website for Industry

Have you noticed the changes in the design of FDA website (http://www.fda.gov/) recently? Last August, I mentioned the FDA's initiatives on transparency. As part of FDA's continued push to increase transparency in an agency once notorious for making decisions behind closed doors, the FDA has launched a new Web-based resource that industry can use to keep abreast of the regulatory status for drugs, devices, food, and cosmetics. The new website is under http://www.fda.gov/ForIndustry/ and is supposed to provide a repository for industries to understand FDA's detail processes in submission, reviewing, approval, and surveillance of the regulated products, and even the processes for complaints (dispute resolution). The website includes the sections that are very pertinent to us working in the pharmaceutical industry:
  • Developing products for rare disease and conditions
  • Dispute resolution
  • Guidance documents
  • FDA eSubmitter
  • Data standards
  • FDA basics for industry
FDA basics for industry includes the kind of basic information about the regulatory process that is often requested by drug, device, and biologic companies and is aimed at improving communication between FDA and industry by making basic information about the regulatory process more accessible to industry in a user-friendly format.

The new website reflects the great improvement towards the transparency and is a great resource for professionals working in the drug development industry.

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