Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because that all-too-familiar routine of meetings, deadlines, and what-not has, predictably, returned. To fortify ourselves, we are brewing cups of stimulation. Our flavor today is chocolate cherry decadence — we went shopping over the weekend — and, as always, we invite you to join us. Before moving on to tidbits, however, we should note that posting will be light as we travel to a soiree with the FDA’s Janet Woodcock. Meanwhile, we hope you have a smashing day and, of course, do stay in touch …
The U.S. Senate tax plan would modify the orphan drug tax credit, unlike the House tax bill that would eliminate the credit altogether, Regulatory Focus tells us. The proposal would limit the level of expenses that would qualify and also limit qualified clinical expenses if they are related to the use of a drug that has previously been approved for diseases or conditions affecting more than 200,000 people in the U.S.
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There is a certain irony that Mylan will be reducing the customer complaint staff, given the observations in the September 2017 warning letter that included lack of ability to properly track and analyze complaints. (Or do they maintain ‘that’s only Meridian/ Pfizer?)
https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm574981.htm