FDA offers "Snapshot" Feature for Clinical and Development Guidelines

Documentation is an important element in the world of GMP. This applies to protocols as well as recording documents. For the field of development, the FDA is now offering a pilot program for a new function called "Snapshot" for their clinical and development guidelines. What's behind it?

To be completely accurate, the tool is called "Guidance Snapshot Pilot." The idea behind it is quite simple. FDA Guidelines represent the current thinking of the FDA and are therefore important for the industry. Especially for the areas of clinical trials and drug development, the FDA now wants to offer the "Guidance Snapshot Pilot" as a way to quickly find information in the relevant guidelines. The "highlights" in the respective guidance documents are pointed out, so to speak. The pilot program is intended to attract attention. The "Snapshot" includes:

  • Explanations of why the guideline is important
  • "Highlights" of the guideline
  • Background information on the guideline topic
  • Link to the full document
  • Drug development timeframes with reference to the application of the guideline recommendations
  • Podcast by guideline authors on "highlights" and background of the guideline in question
  • Twitter hashtag for a platform to discuss the guideline
  • Link to FDA to be able to submit official comments (for draft documents)

However, the FDA's limitation is that the "snapshot" should not be used for drug development decisions. In such cases, the entire document should be consulted.

You can find information on the "Guidance Snapshot Pilot" on the FDA website.

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