- FDA Commissioner Scott Gottlieb, M.D. says the U.S. government shutdown prevents the agency from accepting new product applications under user fee programs (PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA) since it is unable to collect payments.
- In addition, its Center for Biologics Evaluation and Research (CBER) will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and certain other products.
- Its Center for Drug Evaluation and Research (CDER) will pause all over-the-counter monograph drug activities. Emergency work will continue.
- The 30-day review clock for pending IND amendments (non-user fee programs) will be suspended, but will resume when the shutdown is over.
- Emergency INDs and IND amendments will continue to be reviewed, including those under user fee programs.
- About 30% of the drug review process is paid for by appropriations so it will continue in part during the shutdown.
- As everyone should know, the government impasse relates to President Trump's demand for ~$5B for a wall at the U.S./Mexico border.
- ETFs: BIB, GRX, THW, BME, BIS, IXJ, ARKG, GNRX, CHNA, XLV, XBI, VHT, IYH, RYH, IBB, XHE, PJP
- Now read: THW: Sitting Tight With A 12% Yield From This Well-Diversified CEF
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