Nov 02 2010

October 2010 FDA Guidances

Each month, Cato Research Regulatory Scientist Cathy Anderson compiles a list of the notable guidance documents released by the FDA.  Here’s a summary of the guidances released in October 2010 (links go directly to PDF documents).

Special Interest Guidances/Information

Date Posted

Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (Draft) 10/14/2010

Other Recent Guidances

Date Posted
Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application (Draft) 10/13/2010
Qualification Process for Drug Development Tools (Draft)

(Drug development tools such as Biomarkers and Patient reported outcomes)


Other Interesting Information

Manual of Policies and Procedures (MAPP) The Use of Clinical Source Data in the Review of Marketing Applications
Investigational Device Exemption (IDE) – Pivotal IDE Description Summary Form

The Pivotal IDE Descriptive Summary form is completed by FDA reviewers as part of the IDE review process for pivotal trials to provide an accessible summary of the major trial design elements. The information in this Summary assists FDA reviewers in maintaining consistency, where appropriate, across clinical trials for devices similar in design and/or intended use.  A sample copy of this form is now availableso that investigators and others are aware of the key elements of clinical trial design that FDA evaluates in a pivotal IDE application.