My former @US_FDA colleagues have published a very useful article showing how little information becomes public when FDA tells a drug company that its application is not complete enough for review. (1/4) https://pubmed.ncbi.nlm.nih.gov/33587091/ 
Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and...

This cross-sectional study found that the FDA refused to file applications for substantive reasons related to quality, safety, and efficacy, and applicants' disclosure of those reasons was incomple...

https://pubmed.ncbi.nlm.nih.gov/33587091/
It follows on the heels of our previous paper showing similarly that information in letters declining approval for drugs mostly never sees the light of day. (2/4) https://pubmed.ncbi.nlm.nih.gov/26063327/ 
Comparison of content of FDA letters not approving applications for new drugs and associated public...

FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies. In many cases, press releases were not...

https://pubmed.ncbi.nlm.nih.gov/26063327/
Interestingly, when companies file new applications (i.e., good news for investors), the public is almost always made aware. (3/4) https://pubmed.ncbi.nlm.nih.gov/31157824/ 
Public Disclosure of the Filing of New Drug and Therapeutic Biologics Applications With the US Food...

This cross-sectional study reviews New Drug Applications for new molecular entities and Biologics License Applications for new and biosimilar biological products submitted to the US Food and Drug...

https://pubmed.ncbi.nlm.nih.gov/31157824/
The @US_FDA should ensure that researchers, clinicians, and investors have access to all this information – but the agency currently regards all of it as confidential. (4/4)
You can follow @DrPeterLurie.
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