May 22, 2019
Some individuals have an off-kilter sense of risk. They may play it overly safe and refuse to make even the most prudent bets on their development program. Or they may gamble willy-nilly, putting all their chips on wildly unpredictable long shot CMC strategies and preceding advice.
April 16, 2019
The young Isaac Newton is sitting in his garden when an apple falls on his head and, in a stroke of brilliant insight, he suddenly comes up with his theory of gravity. The story is almost certainly embellished, both by Newton and the generations of storytellers who came after him. But from today anyone with access to the internet can see for themselves the first-hand account of how a falling apple inspired the understanding of gravitational force.
March 28, 2019
three rules of engagement are recommended to take place at an End of Phase II meeting, either face to face or by telephone. Each rule helps to ensure a successful negotiating strategy based on the actual discussions with the Agency.
March 7, 2019
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to issue new draft and revised draft quality/chemistry manufacturing and controls (CMC) guidance documents spanning different categories, from biosimilars to microbiology to Pharmaceutical Quality, in 2019.
February 14, 2019
Product development is mainly a sequence of activities. Moving forward to the next step depends upon the result of the previous step. A regulatory deficiency in an early stage will therefore carry forward into all later stages. Fundamental CMC deficiencies at an early stage may require complete subsequent product redevelopment.
January 3, 2019
Since regulatory is an experience-based profession, success is guided by one’s ability to learn from multiple experiences across various projects at different stages of development, which provides an understanding of basic principles that can then be applied to the decision making required for a specific project. Welcome to the our Blog.