Interim Guidance for Human Drug Compounding Outsourcing Facilities

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act.” This draft guidance describes FDA’s current expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound…

FDA Guidance Updates: Procedure and Method Validation

FDA Guidance Updates: Procedure and Method Validation “To improve is to change; to be perfect is to change often.” – Winston Churchill As leaders and supporting players in the pharmaceutical, biotechnology and medical device industries, we commonly recognize the need for FDA guidance, as well as updating guidance documents to support the changing regulatory landscape.  In…