The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons.

The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. released the agency’s “Global Engagement Report”, detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency. The 44 pages report highlights the steps the agency is taking to ensure that imported food, drugs, medical devices, and other regulated products meet the same rigorous standards for safety and quality as those manufactured domestically.

The guideline outlines the requirements for applications that propose RTR (real time release) testing for active substances, intermediates and finished products. It also outlines the different requirements that have to be fulfilled in the application and the need for interaction between quality assessors and GMP inspectors in the approval process.

Japan and Korea resently applied for PIC/S membership.

A new draft of the process validation guideline was published by EMA (European Medicines Ageny) on April 13, 2012,

The PIC/S Committee has adopted an Aide-Mémoire on Assessment of Quality Risk Management Implementation (PI 038-1), which entered  into force on 2 April 2012.

The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.