FDA consulting from the perspective of a regulatory strategist: there exists a space between potential Rx-to-OTC drug candidates, medical devices and nonprescription drugs that is ripe for further drug and device development.
Those manufacturers in both the professional healthcare (prescription) and retail (nonprescription) sectors, are well positioned to capitalize on such opportunities. Those in only one or the other of these sectors would do well to consider broadening their reach.
Adding a delivery device to an old drug or changing any of the following can make an old drug "new" again: dosage form, strength, route of administration, formulation, dosing regimen, combination product, indication, Rx-to-OTC switch. If your organization is looking at ways to diversify, defend existing franchises or expand into new drug or device products, click here to read Rx-to-OTC, OTC-to-Rx, Drug-Device Combinations;
PDG has extensive experience in helping our clients move from drug to device, prescription to nonprescription and vice-versa.