US/Canada – Status of the Dietary Reference Intakes Nomination Process

The Canadian and U.S. governments have each established Federal Dietary Reference Intake (DRI) Committees that work collaboratively to identify DRI needs and to coordinate government sponsorship of DRI reviews and related activities. The DRIs – which reflect nutrient reference values essential to national nutrition policies and to professionals working in the field of nutrition and…

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Current Good Manufacturing Practice—Interim Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C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 This draft guidance describes FDA’s current expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound…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