by Robert Seevers | Jun 8, 2018
Drugs, like any other molecule, are affected by exposure to temperature extremes. Hot and cold can both be the enemy of your product’s quality. How much of a risk is this in the ordinary course of events? Let’s think about how a product moves through the supply chain....
by Robert Seevers | May 9, 2018
In recent blog posts we have analyzed recent U.S. Food and Drug Administration (FDA) guidance topics regarding formal meetings with the FDA and best practices for communicating with FDA during drug development. One topic which we have not addressed is just how to ask...
by Robert Seevers | May 4, 2018
For a long time, people spoke about the problems involved with delivering drugs to people with rare diseases. Development costs were high and regulatory hurdles even higher. Costs were not economically justified by the limited returns expected from a medicine to treat...
by Robert Seevers | Mar 6, 2018
Drug counterfeiting is big business worldwide. The World Health Organization estimates that 1 in 10 medical products in low and middle-income countries either do not meet quality standards or are flat out fake. While the problem is seen with less frequency in the...
by Robert Seevers | Mar 1, 2018
FDA recently published a guidance, Best Practices for Communication Between IND Sponsors and FDA During Drug Development. This is one of several guidances published by FDA in response to User Fee Legislation. This guidance is a joint effort by FDA’s Center for Drug...
