Generic Drug Development: 505(j) ANDAs and Potential Diversification
PDG and staff have participated in over one hundred 505(j) Abbreviated New Drug Applications (ANDA) submissions.
Nonprescription OTC Drug Development
As regulatory strategists, our view of non prescription drug Product development (aka Over-the-Counter or OTC) certainly includes new OTC launches and Rx-to-OTC switches. However, there are many lesser known nonprescription OTC drug development opportunities that PDG can help with. Click through these four Q&As to learn more. As you do so, keep in mind…