Commissioner Gottlieb has been a “very strong champion” of FDA and his interest in improving the OTC monograph and switch processes provides hope to the industry during a tumultuous legislative era, say CHPA executives at their annual meeting in Florida. They expect monograph reform will happen this year but doubt much else will happen before mid-term elections in November.
FDA Commissioner Scott Gottlieb’s interest in OTC drug regulations galvanizes the industry to endure “chaos” on Capitol Hill, amplified by uncertainty about the direction of Congress with mid-term elections approaching, say Consumer Healthcare Products Association executives.
“Since assuming the role of commissioner, Dr. Gottlieb has been a very strong champion of FDA and its mission,” said...
Children with ADHD often struggle with bedtime due to restless minds, difficulty winding down, and heightened sensitivity to nighttime distractions. This article explores the reasons behind these sleep challenges and offers practical solutions.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
David Ball moves from Bayer’s North America business to be Perrigo’s first chief brand and digital officer. He joins CEO who also moved to Perrigo from Bayer with decades of branded product experience.
A draft declaration to be presented to the UN General Assembly in September suggests that a “lack of regulation of over-the-counter use of antimicrobials” is one of the “drivers of antimicrobial resistance.” Industry, however, insists that misuse and over-prescription of antibiotics are the primary drivers of AMR, and is advocating for the text to be amended accordingly.
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A pilot partnership between the FDA and Canada's Medical Devices Programme has been so successful the two agencies will talk this week about how to expand it.
Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.
