In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations for the Center for Biologics Evaluation...
Expertise: Consulting 221 results
Introduction/Background A biotech company could not afford the time and expense of conducting studies recommended by another of its consultants and agreed to by the FDA. The company had previously initiated product development discussions with the FDA based on existing...
Introduction/Background An international company needed a partner with regulatory and strategic development expertise to realize the full potential of its product: a catheter tailored to meet the specific needs of a drug designed to cure an organ cancer. The client’s...
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...
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 FDA recently released draft guidance on changes to pediatric study...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...