FDA implied that industry was not responsive to the data request from TPSAC. However, upon questioning by members of a committee, it appears that industry submitted hundreds of pages of information. CRE is perplexed by the negative tone of the FDA presentation. What is the FDA’s bottom line concern?
What’s the Beef?
My view is that the FDA KNOWS there exists some “Smoking Gun” from within industry. Guilty; now just a little proof.
As “Not Einstein” noted, the FDA is looking for the “Smoking Gun.” Industry reports, memos, and databases of lab and production data are meaningless to FDA staff and leadership because they simply will not invest the time and efforts it takes to READ THE LITERATURE. Industry technical reports are boring unless you are really into the science and know what to look for. Also, those running the UCSF legacy library should read the tremendous wealth of excellent scientific literature in their library.