Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie?

Rx-to-OTC, OTC-to-Rx Switch, Drug-Device Combinations; Where do the opportunities lie? 6 MUST READ SCENARIOS

Medical Device Consulting News, Pharmaceutical Consulting News, Research & Development, Submissions

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.”…

Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced

Labeling / Marketing, Pharmaceutical Consulting News, Regulatory Affairs, Regulatory Updates, Research & Development, Submissions

According to FDA, “This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-the-counter (OTC) drug monograph system and to describe the process for submitting that  information. FDA regulations set forth criteria and procedures by which…