US FDA Consulting: Six Must-Read Scenarios
FDA consultants and regulatory strategists, we recognize that the space between nonprescription drugs, medical devices and prescription drugs FDA may consider ripe for Rx-to-OTC switches represent tremendous potential.
Put simply, changing an approved drug or cleared medical device generally yields a new drug or device (e.g. creating a combination product by adding a drug delivery device to an existing medication, changing dosage form, strength, route of administration, formulation, dosing regimen, indication, or effecting an Rx-to-OTC switch).
PDG recognizes that many in the health professional (prescription) market are reluctant to explore entry into the retail (nonprescription) market. Reluctance with drug development in organizations previously focused on medical devices (and vice-versa) is also commonplace.
However, it is those who are reluctant to do so that make this such a great opportunity for those who are willing to broaden their reach. This also characterizes the value of PDG to any company considering such moves.