Hello, everyone, and nice to see you again after we engaged in an extended respite. We took the opportunity to recharge and reflect, but now, of course, have returned to the usual routine of deadlines and calls and the like. So time to fire up the coffee kettle and quaff a few cups of stimulation. We are starting today with glazed doughnut, since one can never be too sweet, yes? Meanwhile, here are a few tidbits to get you going. We hope you have a meaningful and productive day. And of course, please do keep in touch. We appreciate your tips and insights. …
If U.S. lawmakers are unable to negotiate a deal to prevent a government shutdown by Oct. 1, the U.S. Food and Drug Administration will have to furlough almost one-fifth of its staff and halt work that could have a critical impact on medical-products industries, Regulatory Focus says. As a government shutdown looms, FDA published a contingency plan stating it will immediately have to furlough 19% of its staff until it receives more funds. Under the law, the FDA can retain 64%, or 12,300 staff members, who are considered exempt from appropriations because they are either funded through the executive branch, carryover user fees, Working Capital Fund, or Covid-19 supplemental funding.
The FDA disclosed it has deep reservations about NurOwn, an investigational ALS treatment from BrainStorm Cell Therapeutics, citing a lack of evidence the medicine works and a failure to demonstrate the company can properly manufacture the drug, STAT writes. In documents posted ahead of a Wednesday public hearing, the FDA detailed its problems with a clinical trial that missed its primary objective and noted BrainStorm submitted “grossly deficient” information on how the medicine is made, voicing “major concerns that the available data do not meet the statutory standard of substantial evidence of effectiveness to support” approval.