The discovery and development of a new medicine is a complex and lengthy process. Many founders begin their search for a new therapy without understanding these details. In my experience, most of the public views drug development as “the news reports that scientists...
Medical Products
Making a New Medicine Part 2: Introducing Clinical Trials
The discovery and development of new medicines is a complex and lengthy process. Many founders begin their search for a new therapy without an understanding of these details. In my experience, most of the public views drug development as “the news reports that...
Making a New Medicine Part 1: Discovery and Development
The discovery and development of a new medicine is a complex and lengthy process. Many founders begin searching for a new therapy without understanding these details. In my experience, most of the public views drug development as “the news reports that scientists show...
Tools for Transforming Drug Development
Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after one round of revision and comments on the original draft published in 2014. With this document, titled "Qualification Process for Drug...
The CDERDirect NextGen Collaboration Portal
Rapid and secure communication with the FDA is an essential task within the regulated industry, and CDER makes some communications easier through the NextGen Collaboration portal. This tool is part of the FDA's efforts to streamline and modernize the drug development...
The FDA’s Approach to DHT is Evolving
The FDA’s thinking on Digital Health Technologies (DHT) continues to evolve. They released the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March. This publication, a PDUFA VII commitment, will “guide activities...
What is Pharmaceutical Advanced Manufacturing?
Pharmaceutical manufacturing has traditionally been a batch-based process, with different stages of production being conducted in discrete steps. However, in recent years there has been an increasing interest in continuous manufacturing as an alternative to...
Turnaround Time and Success Rate for Medical Device Decisions
All medical device companies need to include a success rate and time to decision for their submissions in their go-to-market plan. It turns out that helpful information on both subjects is readily available from the FDA.