Introduction/Background The 505(b)(2) new drug application pathway offers unique advantages that can save sponsors significant time and money. Leveraging the 505(b)(2) process, our biotech customer achieved paper NDA approval for a parenteral acute-use drug. While no new nonclinical studies were...
Expertise: Consulting 228 results
Introduction/Background A biotech company targeted a new oncology indication with an improved delivery technology for an already approved drug. Because the active pharmaceutical ingredient had previously been approved, the company believed it could leverage the 505(b)(2) pathway to seek FDA...
Consulting
What is 505(b)(2)?
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration (FDA) drug approval pathways and represents an appealing regulatory strategy for many clients. The pathway was created by the Hatch-Waxman Amendments of 1984, with 505(b)(2)...
If you are planning to submit a New Drug Application (NDA) for an oncology drug product in 2020, revised pediatric study plan requirements could have an impact on the submission. FDA recently released draft guidance on changes to pediatric study...
Consulting
Drug Development for an Aging Population
Fueled by unprecedented medical, technological and social advancements of the past century, it should be no surprise that we are living longer than ever before. By 2030, more than one in four people in Europe and North America will be...
To succeed in today’s highly competitive pharmaceutical landscape, differentiation is key. In recent years, many generics companies have turned their focus to niche products, complex generics, or biosimilars to achieve this differentiation. During the 3rd Annual Portfolio Management Strategies for...
With drug discovery completed and your lead asset identified, it’s time to initiate IND-enabling activities, moving one step closer to clinical deployment. According to the Tufts Center for the Study of Drug Development, fewer than 10 percent of nonclinical lead...
A pharmaceutical company is granted orphan designation for a medicine that treats Hunter Syndrome. The company goes on to receive marketing approval for the medicine. The approved medicine is administered through intravenous infusion. This route of administration, while effective for...
Yesterday, FDA released draft guidance on the use of the Inactive Ingredient Database (IID) in drug development. The guidance is one step FDA is taking to address feedback from the generics industry that IID enhancements are needed to help sponsors make the right formulation...
As part of nationwide efforts to address the opioid crisis, FDA is taking a closer look at the development of critical medications that combat overdose deaths. Most recently, FDA announced its intention to prioritize review of ANDAs for drug products...