Newsletter - December 10, 2015
FDA is Seriously Concerned about Lab Developed Tests and Wants to Regulate Them Strictly
About three weeks ago, on 16th November 2014, FDA released an internal report highly critical of Lab Developed Tests (LDTs) using 20 such tests as examples. This report highlights several of FDA’s concerns regarding LDTs. According to this report, unregulated LDTs are dangerous to the public not only by giving false positive or negative results, but also claiming unproven ideas and financial loss to consumers. This report was also highlighted in a blog that day by FDA’s Associate Commissioner for Public Health Strategy and Analysis, Dr. Peter Laurie, indicating FDA’s assertion that regulation of LDTs is a major public health issue in the coming years. Read More..
Best Practices for Meetings with FDA: New Guidance, “Old” Information
Sometimes you see a new guidance document from FDA and you scratch your head, trying to understand the intent of this new document and then it dawns on you; FDA is trying its best to help the novice sponsors understand internal processes. Last week, FDA released a new Guidance Document on best practices to discuss with FDA, not just in meetings with the reviewers but also other ways such as emails, phone calls, faxes (if you still use them), and by making submissions asking specific questions. If you have a reasonable experience interacting with FDA in the recent past, this is not for you. Read More..
FDA is Seriously Concerned about Lab Developed Tests and Wants to Regulate Them Strictly
About three weeks ago, on 16th November 2014, FDA released an internal report highly critical of Lab Developed Tests (LDTs) using 20 such tests as examples. This report highlights several of FDA’s concerns regarding LDTs. According to this report, unregulated LDTs are dangerous to the public not only by giving false positive or negative results, but also claiming unproven ideas and financial loss to consumers. This report was also highlighted in a blog that day by FDA’s Associate Commissioner for Public Health Strategy and Analysis, Dr. Peter Laurie, indicating FDA’s assertion that regulation of LDTs is a major public health issue in the coming years. Read More..
Best Practices for Meetings with FDA: New Guidance, “Old” Information
Sometimes you see a new guidance document from FDA and you scratch your head, trying to understand the intent of this new document and then it dawns on you; FDA is trying its best to help the novice sponsors understand internal processes. Last week, FDA released a new Guidance Document on best practices to discuss with FDA, not just in meetings with the reviewers but also other ways such as emails, phone calls, faxes (if you still use them), and by making submissions asking specific questions. If you have a reasonable experience interacting with FDA in the recent past, this is not for you. Read More..
