OTC drug development and marketing consultants discuss FDA allowing simultaneous Rx and OTC sales of same drug formulation with the same indication and about opportunities for follow-on generic equivalents of switches approved as additional condition for nonprescription use OTCs.
A proposed US rule to facilitate OTC switches for chronic conditions would bend two basic rules of drug regulation, one keeping approvals of Rx and nonprescription drugs separate and the other setting approval requirements for follow-on generic equivalents of switched products.
Both pieces of the Food and Drug Administration’s “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” proposed...
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.
Following Energy and Commerce Health Subcommittee hearing about FDA’s human food and tobacco programs on 10 September, gap between what the trade groups, committee leadership and the FDA each want more of doesn’t appear to be shrinking.
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.
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.
