Newsletter - August 10, 2017
The Promise and Perils of the Pre-Cert Program for Software Developers
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. Read More
FDA Explains What Is a Minor Change in Biologics Manufacturing: Core Principle for All GMP Process Changes
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. Read More
The Promise and Perils of the Pre-Cert Program for Software Developers
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. Read More
FDA Explains What Is a Minor Change in Biologics Manufacturing: Core Principle for All GMP Process Changes
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. Read More