What is a Biosimilar and How Does it Differ Compared to Drug Development?

Many of today’s most important medications are biologics. Among the notable conditions treated by biologics are rheumatoid arthritis, anemia, low white blood cell counts, inflammatory bowel disease, skin conditions and various forms of cancer. As you probably perceive, biosimilars are to biologics what generic drugs are to brand-name drugs. However, there are major differences between…

Pharmacokinetics in Drug Development

Pharmacokinetics in Drug Development Related to ANDA/505(b)(2) Submissions

As pharmaceutical consultants, the scientists and regulatory professionals at PDG® design pharmacokinetic (PK) protocols for a wide variety of applications. This paper has been written to provide the reader with a basic review of pharmacokinetic and pharmacodynamics (PD) principles as well as an exposure to a cross section of the utility of PK studies. While…

Seven Noteworthy 505(b)(2) Submissions

Seven Noteworthy 505(b)(2) Submissions

As drug and device consultants, the scientists and regulatory experts at PDG® spend a considerable amount of time working on 505(b)(2) NDA submissions. This paper highlights notable features of a cross section of recent 505(b)(2) approvals and provides a variety of everyday issues to consider as you contemplate your next drug development project. Generic companies…

Which Regulatory Path Should I Choose for FDA Combination Products?

With FDA Combination Products on the Rise, a Common Question is, “Which regulatory path should I choose?”

What is a Combination Product? In a world in which we are continuously challenged to operate more efficiently and immersed in rapid technological advances, it should come as no surprise that one of today’s fastest growing medical product segments are combination products. To be considered a combination product by FDA, there must be two or…