First-in-Class Switch Approvals: Oral Contraceptives and Opioid Overdose Treatment
Much to the delight of American women, oral contraceptives, known as “the pill,” will now be available without a prescription.
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Will the FDA’s OTC Monograph Reform Foster Innovation Including Increased Rx-to-OTC Switch Activity?
After years of the OTC industry and the Consumer Healthcare Products Association working with the FDA to pass long-overdue OTC monograph reform and regulatory modernization, long-sought-after reform is now a reality thanks to the CARES (Coronavirus Aid, Relief, and Economic Security) Act. The act, which was passed by the U.S. Congress and signed into law
To ban or not to ban triclosan? That is the question.
On December 16, 2013, the Food and Drug Administration (FDA) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. The FDA
FDA Initiative Forms Basis for Healthy Rx-to-OTC Switch Opportunities
In the not so distant past, the U.S. FDA has taken a rather conservative stance concerning Rx-to-OTC switches. Many potential categories have been discounted as not safe and/or effective without a physician’s prescription. This has compelled drug manufacturers to judiciously consider which drugs, if any, they would seek to switch given the necessary multi-million dollar
