In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for...
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In March 2020, at the start of the COVID-19 pandemic, the FDA issued guidance on the conduct of clinical trials. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,”...
As we continue to face health emergencies and imminent threats to our safety and well-being, the medical community is tasked with bringing solutions to the patients in an expedited and safe manner. One such opportunity is to partner with the...
Transdermal and topical delivery systems (TDS) are important dosage forms that allow delivery of a drug to local tissue or provide systemic delivery through the skin. These drug products provide a number of advantages for patients, but can be challenging...
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...
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...
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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)...