Day: August 10, 2017

The manufacturing process for any given FDA-regulated product could go through several changes, each of which needs to be reported to the FDA on a schedule based on the scope of the change. Manufacturers play it safe by sending most changes immediately which clogs the FDA reviewers’ time. This week FDA released a guidance to … Read more

Last week we discussed FDA’s revolutionary update to software regulation, namely establishment of a pilot pre-certification program for software developers with demonstrated high quality operations. This week FDA released its first guidance on the pre-cert program, in a question and answer format, further clarifying how the pre-cert pilot will work. The pre-cert program is open … Read more