As a prescription and OTC pharmaceutical consultant, I am repeatedly amazed by the successes resulting from the simplest of drug & device development ideas. While it may be legend, it is said that Charles H. Duell, Commissioner of the US Patent Office in 1899 coined the phrase “everything that can be invented has been invented.”…
First approved in 1996, FDA recently approved a supplemental NDA (20380/S-010) for Differin® Gel (adapalene), 0.1% to be marketed as a nonprescription product in 2, 15, and 45 gram containers. In the approval letter, FDA noted that “usage and exposure were key review issues in our evaluation of the potential risks of nonprescription marketing. Research…
According to FDA, Consumers should “Take a close look at the Drug Facts label, and if the product has aspirin, consider choosing something else for your stomach symptoms,” Click here for the full story or here to learn more about OTC drug development.
On August 29, 2011, Public Citizen filed a Citizen Petition calling for FDA to authorize ANDA holders to change approved generic labeling using Changes Being Effected (CBE) supplements (among other changes). In response, on November 13, 2013, FDA issued notice of a proposed rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”…
Medical device consultants on another lesser known, yet beneficial FDA program It’s time to submit another run of the mill traditional 510(k) for your medical device = same old fee, same old timeframe. You are just going to submit your 510(k) to the FDA per usual and wait 90 days for feedback, or hopefully that…