Next step for OTC monograph reform legislation is Senate consideration; market exclusivity periods are likely focus of House/Senate conference. Separate bill to allow consumers to use health savings accounts to buy OTC drugs without a doctor's prescription clears House Ways and Means panel.
The House has been busy on consumer health products policy, making progress on one proposal to streamline how FDA evaluates OTC monograph proposals and another on how consumers can pay for nonprescription drugs.
On July 16, the full chamber passed the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333. It...
The gut’s microbiome will shape future medical advances, offering personalized therapies and prevention strategies for a wide range of diseases.
P&G's FY2024 Q4 net sales were flat at $20.5bn, lower than consensus estimates, but the firm says its underlying business divisions are healthy and forecasts FY2025 sales up 2% to 4%, up 3% to 5% organically.
Legislator education is key to checking state bills that overreach, says Ross, executive VP of government affairs at the Personal Care Products Council, discussing the rising tide of US state bills aimed at restricting ingredient use.
FDA reminds companies which registered with agency solely to manufacture OTC sanitizers during COVID-19 public health emergency they will be subject to FY2025 OTC monograph user fees if they don’t delist and deregister as monograph drug manufacturers by 12 a.m. on 31 December.
With monographs@FDA portal down, agency moves to NextGen and extends comment period through 27 September for first OTC monograph change it proposed using its overhauled program other than 32 monographs finalizations required in 2020 legislation authorizing overhaul.
OTC sales edged up at Italy's Recordati in the first half of 2024 as higher demand for GI products and supplements offset a weaker cold & flu season.
P&G's FY2024 Q4 net sales were flat at $20.5bn, lower than consensus estimates, but the firm says its underlying business divisions are healthy and forecasts FY2025 sales up 2% to 4%, up 3% to 5% organically.
