FDA publishes List of Guidances planned for 2015

At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. Find out more about the Guidances the FDA plans on publishing in 2015.

http://www.gmp-compliance.org/enews_4660_FDA-publishes-List-of-Guidances-planned-for-2015_9293,9266,Z-QAMPP_n.html

At the beginning of each year the FDA always publishes a list of the guidances it plans to publish during that year. It has done so again in 2015. The document is relatively comprehensive, containing five pages. The list is subdivided into different categories. It contains for example also guidances planned in connection with the topics Clinical Pharmacology or Clinical/Statistical.

CGMP is a category of its own for which “only” three new guidances are planned for 2015:

• A questions & answers (Q&A) paper on the topic data integrity
• CGMP rules for outsourced facilities (pharmacy compounding)
• Rules for the…