With “improbable dosing in approximately 1/3 of participants” in HRA actual use study, FDA asks advisory committees to recommend design changes if it asks firm for another study. FDA asked HRA to explain discrepancies after it began reviewing the firm’s sNDA submitted in June 2022.
Concerns about a portion of the study supporting a proposal for an Rx-to-OTC switch of 0.075-mg norgestrel as a daily oral contraceptive in the US have prompted the Food and Drug Administration to ask an advisory panel to recommend a better study.
In addition to asking whether the Nonprescription Drug and the Obstetrics, Reproductive and Urologic Drugs advisory committees, during a joint...
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.
To make your document look professionally produced, Word provides header, footer, cover page, and text box designs that complement each other. For example, you can add a matching cover page, header, and sidebar. Click Insert and then choose the elements you want from the different galleries.
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.
