FDA: Guidance Agenda 2014

The FDA has released its yearly guidance agenda which includes the new and revised draft guidance’s CDER is planning to publish during the calendar year 2014.

According to FDA, in the category “Quality: Facility, Production and Process Control” the following publications can be expected:

•  Contract Manufacturing Arrangements for Drugs: Quality Agreements

•  GXP Consideration for Outsourced IT (Cloud Computing) Systems in Medical Product Manufacturing and Clinical     Study Environments

•  Interim Good Manufacturing Practice for Human Drug Compounding Outsourcing Facilities Under Section 503 B of     the Federal Food, Drug and Cosmetic Act

•  Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice

•  Submission of Field Alert Reports and Biological Product Deviation Reports. View full document CLICK HERE