505(b)(2) Regulatory Planning: Designing Streamlined Programs to Create Value for Patients and Sponsors
Sponsors can use the 505(b)(2) pathway to develop drugs with new indications, dosage forms or strengths, formulations, dosing regimens, routes of administration, or even active ingredients. In many cases, these changes create new, differentiated products that patients or healthcare providers prefer over previous versions, leading to both improved experiences for patients and tremendous commercial value...