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Some sort of "pharmacy intervention" could aid switches, CEO Hendrickson says; board bloc is still pushing to divest the generic Rx segment but apparent second-quarter sales validation isn't enough to persuade Hendrickson to stay on.
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Homeolab USA’s and Cellex-C’s imports were stopped earlier in 2017 following GMP inspections at their facilities, and FDA warns that approvals for marketing of additional products in the US could be withheld until each firm is GMP-complaint. Homeolab trips up by trying to prevent FDA photography inside plant.
The National Health Service in England has drawn up a proposed list of “ineffective and dangerous” medicines that should not be routinely used in primary care, in a move to conserve resources and improve patient outcomes. They include products containing substances like fentanyl, tadalafil and trimipramine, as well as homeopathics and traditional herbal medicines.
FDA’s Aug. 23 webinar will update industry stakeholders on progress to modernize its OTC monograph program, but without user fee legislation, new performance goals will not take effect; stakeholders hold out hope a standalone OTC user fee bill could still progress in Congress.
In a reminder that the agency hasn't forgotten past tragedies, FDA warns Philippine OTC firm Skin Sciences to test glycerin raw material for diethylene glycol if it wants to keep selling toothpaste in the US.
“There is a ton of work still for us to do,” Erica Mann, Bayer’s global consumer head, said after the firm reported disappointing second-quarter results. The root of the problem is over-estimating the revenue boost from former Merck & Co. brands, the firm says.
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