Top of the morning to you, and a fine one it is. Blue skies and cool breezes are enveloping the Pharmalot campus, where the short person is sleeping in and the official mascot is recovering from a long walk with Mrs. Pharmalot. As for us, we are quaffing multiple cups of stimulation to fortify us for what looks to be a busy day ahead. No doubt, you may relate. So time to get cracking. Here are a few items of interest to get you going. Hope you conquer the world today, but of course, do stay safe. …
Stephen Hahn, a political novice who moved to Washington in December to take over the Food and Drug Administration, has found himself steering his agency through the most tumultuous time in its history, STAT explains. But with almost no institutional knowledge behind him, FDA experts worry he’s flying blind, leaving the agency flailing despite its vital role in the effort to control the spread of Covid-19. And now, the career cancer doctor is suddenly at the center of a fight for his agency’s integrity — and for his own.
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Ah, FDA will not collect data as mandated by the CARS Act. Why? Blame the programmers … “While the requirements established under Section 3112 are set to take effect on 23 September 2020, FDA says the electronic data submission portal it intends to use will not be ready by that date.”
Now would the Agency let Industry get away with this?